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TerminatedNCT03318523SPARKUpdated Feb 28, 2022Results posted

Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

A Phase 2 interventional study of Placebo and BIIB054 in Parkinson's Disease, sponsored by Biogen. Terminated at 75 sites in 9 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-28.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Why this study was terminated
SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed.
Phase
Phase 2
Study type
Interventional
Enrollment
357
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.

The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • BIIB054
  • Alpha-synuclein
03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
  • Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
  • Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
  • Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
  • All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.

Exclusion criteria

Exclusion Criteria:

  • Presence of freezing of gait.
  • Montreal cognitive assessment (MOCA) score \<23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
  • History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
  • History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
  • Participation in any active immunotherapy study targeting alpha-synuclein.
  • Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
  • Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
  • Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).

NOTE : Other protocol defined Inclusion/Exclusion criteria may apply

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
357 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Year 1: Participants will receive matching placebo to BIIB054 on Day 1 and then every 4 weeks. Year 2: Participants who received placebo in year 1 will be randomized into one of the active treatment arms in year 2 and will receive BIIB054 intravenous (IV) infusion on Week 52 and then every 4 weeks.

    Drug: Placebo

  • Experimental
    BIIB054 250 mg

    Participants will receive BIIB054 250 milligrams (mg) intravenous (IV) infusion on Day 1 and then every 4 weeks.

    Drug: BIIB054

  • Experimental
    BIIB054 1250 mg

    Participants will receive BIIB054 1250 mg IV infusion on Day 1 and then every 4 weeks.

    Drug: BIIB054

  • Experimental
    BIIB054 3500 mg

    Participants will receive BIIB054 3500 mg IV infusion on Day 1 and then every 4 weeks.

    Drug: BIIB054

Interventions

  • DrugPlacebo

    Administered as specified in the treatment arm

  • DrugBIIB054

    Administered as specified in the treatment arm.

05

What researchers measure

Primary outcomes

  1. Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  2. Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 72

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.

    Time frame: Up to 3 years

  2. Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 96

  3. Serum Concentration of BIIB054

    Time frame: Pre-dose and 1 hour post-dose of Baseline, Weeks 4, 8, 12, 16, 24, 32, 36, 44, 52, 60, 68, 84, 96, 120 and 144

  4. Change From Baseline in MDS-UPDRS Subpart I Score at Week 52

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  5. Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Weeks 72 and 96

  6. Change From Baseline in MDS-UPDRS Subpart II Score at Week 52

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  7. Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Weeks 72 and 96

  8. Change From Baseline in MDS-UPDRS Subpart III Score at Week 52

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  9. Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

    Time frame: Baseline, Weeks 72 and 96

  10. Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52

    SBR in the putamen as measured by SPECT imaging of the dopamine transporter (DaT) with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  11. Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52

    SBR in the striatum as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  12. Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52

    SBR in the caudate as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.

    Time frame: Baseline, Week 52

  13. Percentage of Participants With Anti-BIIB054 Antibodies in the Serum

    Time frame: Up to Week 144

06

Results

Posted Nov 23, 2021
Limitations and caveats
The study did not meet its primary outcome measure for year 1 and did not demonstrate efficacy on key secondary outcome measures; additional pre-specified analyses at week 72 confirmed the study did not provide evidence of efficacy; resulting in the development of BIIB054 for Parkinson's disease to be discontinued and SPARK study was closed.

Participant flow

Participants were enrolled at 75 investigational sites from 10 January 2018 to 29 April 2021.

PC Period: Up to Year 1
Participant flow — PC Period: Up to Year 1
MilestonePC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)DBE Period: Placebo to BIIB054 250 mg (Delayed Start)DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)DBE Period: BIIB054 250 mg (Early Start)DBE Period: BIIB054 1250 mg (Early Start)DBE Period: BIIB054 3500 mg (Early Start)
Started10055102100000000
Completed965310096000000
Not completed4224000000
Withdrew: Adverse event1020000000
Withdrew: Consent withdrawn3204000000
DBE Period:Year 2 to EOS (Up to 3 Years)
Participant flow — DBE Period:Year 2 to EOS (Up to 3 Years)
MilestonePC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)DBE Period: Placebo to BIIB054 250 mg (Delayed Start)DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)DBE Period: BIIB054 250 mg (Early Start)DBE Period: BIIB054 1250 mg (Early Start)DBE Period: BIIB054 3500 mg (Early Start)
Started00002037395210096
Number of participants dosed00002037395210094
Completed0000000000
Not completed00002037395210096
Withdrew: Adverse event0000100102
Withdrew: Consent withdrawn0000100132
Withdrew: Investigator decision0000010000
Withdrew: Death0000000001
Withdrew: Study terminated by sponsor0000173639489491
Withdrew: Other0000100230

Outcome measures

PrimaryChange From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · score on a scale
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52
score on a scalePC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 5210.78 ± 1.49010.48 ± 1.95111.29 ± 1.44610.86 ± 1.518
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.8976 · Difference: -0.30 · 95% CI -4.888 to 4.287
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.7960 · Difference: 0.50 · 95% CI -3.310 to 4.312
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.9695 · Difference: 0.08 · 95% CI -3.805 to 3.956
PrimaryChange From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 72
Reported as:
Mean · score on a scale
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72
score on a scalePC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 727.11 ± 1.4766.83 ± 2.0328.66 ± 1.4966.94 ± 1.508
Statistical analysis
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.9093 · Difference: -0.28 · 95% CI -5.035 to 4.483
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.4327 · Difference: 1.55 · 95% CI -2.336 to 5.440
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model with repeated Measures · p = 0.9330 · Difference: -0.17 · 95% CI -4.051 to 3.719
SecondaryPercentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.

Time frame:
Up to 3 years
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
percentage of participantsPC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
AEs77.185.589.293.0
SAEs8.310.98.812.0
SecondaryChange From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 96
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96
score on a scalePC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 967.88 ± 1.6168.28 ± 2.3178.71 ± 1.6288.87 ± 1.659
Statistical analysis
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.8828 · Difference: 0.41 · 95% CI -5.013 to 5.825
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measure · p = 0.7019 · Difference: 0.84 · 95% CI -3.458 to 5.128
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.6519 · Difference: 0.99 · 95% CI -3.323 to 5.301
SecondarySerum Concentration of BIIB054
Time frame:
Pre-dose and 1 hour post-dose of Baseline, Weeks 4, 8, 12, 16, 24, 32, 36, 44, 52, 60, 68, 84, 96, 120 and 144
Reported as:
Mean · micrograms per milliliter (ug/mL)
Serum Concentration of BIIB054
micrograms per milliliter (ug/mL)BIIB054 250 mgBIIB054 1250 mgBIIB054 3500 mg
Baseline (Pre-dose)0.00 ± 0.0007.47 ± 51.2810.01 ± 0.065
Baseline (1 Hour Post-dose)75.02 ± 15.829374.79 ± 86.0041137.28 ± 335.336
Week 4 (Pre-dose)20.37 ± 5.00495.36 ± 27.882306.20 ± 95.257
Week 4 (1 Hour Post-dose)97.09 ± 19.711468.56 ± 190.5891354.19 ± 364.468
Week 8 (Pre-dose)29.73 ± 8.371169.79 ± 68.025495.79 ± 153.357
Week 8 (1 Hour Post-dose)103.69 ± 26.964543.91 ± 143.2121591.57 ± 465.798
Week 12 (Pre-dose)36.76 ± 11.830195.16 ± 51.020580.43 ± 185.761
Week 12 (1 Hour Post-dose)112.61 ± 27.378569.41 ± 141.2501632.29 ± 459.839
Week 16 (Pre-dose)40.82 ± 11.421201.33 ± 73.451642.06 ± 194.288
Week 16 (1 Hour Post-dose)117.08 ± 27.401614.85 ± 186.8921739.98 ± 506.346
Week 24 (Pre-dose)43.31 ± 12.906235.69 ± 84.454724.60 ± 228.295
Week 24 (1 Hour Post-dose)125.79 ± 36.695664.26 ± 209.2511867.92 ± 470.283
Week 32 (Pre-dose)42.69 ± 13.486260.35 ± 104.397772.75 ± 299.703
Week 32 (1 Hour Post-dose)139.00 ± 34.758626.16 ± 164.4971985.71 ± 497.545
Week 36 (Pre-dose)45.77 ± 11.867262.80 ± 85.052819.83 ± 328.774
Week 36 (1 Hour Post-dose)123.67 ± 29.536665.60 ± 145.2351916.84 ± 543.373
Week 44 (Pre-dose)58.17 ± 22.774280.40 ± 116.590858.43 ± 349.573
Week 44 (1 Hour Post-dose)143.33 ± 41.004582.40 ± 194.4312066.25 ± 579.555
Week 52 (Pre-dose)46.70 ± 19.343232.08 ± 87.529787.35 ± 341.229
Week 52 (1 Hour Post-dose)114.59 ± 25.913645.36 ± 264.2701920.78 ± 479.511
Week 60 (Pre-dose)43.41 ± 15.973254.52 ± 88.446724.77 ± 314.854
Week 60 (1 Hour Post-dose)122.55 ± 29.374657.94 ± 149.6541905.43 ± 494.136
Week 68 (Pre-dose)706.25 ± 966.969202.33 ± 34.2101362.50 ± 533.866
Week 68 (1 Hour Post-dose)171.50 ± 44.548576.33 ± 85.2902305.00 ± 1025.305
Week 84 (Pre-dose)47.00 ± 15.535255.54 ± 81.407746.43 ± 249.770
Week 84 (1 Hour Post-dose)134.91 ± 33.035648.62 ± 120.1631942.02 ± 501.095
Week 96 (Pre-dose)41.25 ± 15.345274.56 ± 71.718654.70 ± 262.926
Week 96 (1 Hour Post-dose)122.00 ± 29.527682.30 ± 123.6531822.50 ± 475.682
Week 120 (Pre-dose)34.98 ± 12.042279.00 ± 99.499727.29 ± 116.793
Week 120 (1 Hour Post-dose)119.67 ± 15.629769.83 ± 279.1821717.14 ± 320.037
Week 144 (Pre-dose)—365.00 ± NA—
Week 144 (1 Hour Post-dose)—721.00 ± NA—
SecondaryChange From Baseline in MDS-UPDRS Subpart I Score at Week 52

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Subpart I Score at Week 52
score on a scalePC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in MDS-UPDRS Subpart I Score at Week 521.43 ± 0.4360.90 ± 0.5701.56 ± 0.4231.65 ± 0.446
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.4327 · Difference: -0.53 · 95% CI -1.851 to 0.794
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.8155 · Difference: 0.13 · 95% CI -0.965 to 1.225
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.7015 · Difference: 0.22 · 95% CI -0.899 to 1.334
SecondaryChange From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Weeks 72 and 96
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96
score on a scalePC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
Change from Baseline at Week 721.65 ± 0.3950.61 ± 0.5381.73 ± 0.4021.63 ± 0.405
Change from Baseline at Week 961.95 ± 0.3981.69 ± 0.5681.93 ± 0.4031.72 ± 0.414
Statistical analysis
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.1038 · Difference: -1.03 · 95% CI -2.276 to 0.213
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.8689 · Difference: 0.09 · 95% CI -0.933 to 1.103
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.9820 · Difference: -0.01 · 95% CI -1.026 to 1.003
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.6930 · Difference: -0.26 · 95% CI -1.563 to 1.040
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.9606 · Difference: -0.03 · 95% CI -1.053 to 1.001
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.6512 · Difference: -0.24 · 95% CI -1.269 to 0.794
SecondaryChange From Baseline in MDS-UPDRS Subpart II Score at Week 52

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Subpart II Score at Week 52
score on a scalePC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in MDS-UPDRS Subpart II Score at Week 523.17 ± 0.4732.72 ± 0.6213.16 ± 0.4603.01 ± 0.486
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.5497 · Difference: -0.44 · 95% CI -1.889 to 1.007
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.9980 · Difference: -0.00 · 95% CI -1.200 to 1.197
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.8069 · Difference: -0.15 · 95% CI -1.374 to 1.070
SecondaryChange From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Weeks 72 and 96
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Subpart II Score at Weeks 72 and 96
score on a scalePC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
Change from Baseline at Week 721.83 ± 0.4911.62 ± 0.6722.36 ± 0.4971.68 ± 0.503
Change from Baseline at Week 961.87 ± 0.5291.33 ± 0.7622.39 ± 0.5332.22 ± 0.541
Statistical analysis
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.7968 · Difference: -0.21 · 95% CI -1.786 to 1.372
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.4211 · Difference: 0.53 · 95% CI -0.766 to 1.827
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.8166 · Difference: -0.15 · 95% CI -1.448 to 1.143
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.5535 · Difference: -0.53 · 95% CI -2.310 to 1.240
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.4654 · Difference: 0.52 · 95% CI -0.881 to 1.922
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.6184 · Difference: 0.36 · 95% CI -1.051 to 1.763
SecondaryChange From Baseline in MDS-UPDRS Subpart III Score at Week 52

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Subpart III Score at Week 52
score on a scalePC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in MDS-UPDRS Subpart III Score at Week 526.10 ± 1.0836.69 ± 1.4196.76 ± 1.0466.20 ± 1.104
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.7274 · Difference: 0.59 · 95% CI -2.742 to 3.925
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.6385 · Difference: 0.66 · 95% CI -2.094 to 3.411
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.9467 · Difference: 0.10 · 95% CI -2.718 to 2.910
SecondaryChange From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.

Time frame:
Baseline, Weeks 72 and 96
Reported as:
Mean · score on a scale
Change From Baseline in MDS-UPDRS Subpart III Score at Weeks 72 ad 96
score on a scalePC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
Change from Baseline at Week 723.64 ± 1.0274.48 ± 1.4044.49 ± 1.0383.69 ± 1.048
Change from Baseline at Week 964.49 ± 1.1745.14 ± 1.6794.39 ± 1.1805.17 ± 1.201
Statistical analysis
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.6112 · Difference: 0.85 · 95% CI -2.423 to 4.114
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.5270 · Difference: 0.86 · 95% CI -1.806 to 3.520
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.9673 · Difference: 0.06 · 95% CI -2.608 to 2.719
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 250 mg · Mixed Model for Repeated Measures · p = 0.7455 · Difference: 0.65 · 95% CI -3.274 to 4.569
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 1250 mg · Mixed Model for Repeated Measures · p = 0.9506 · Difference: -0.10 · 95% CI -3.192 to 2.997
  • PC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled) vs PC Period: Early Start BIIB054 3500 mg · Mixed Model for Repeated Measures · p = 0.6643 · Difference: 0.69 · 95% CI -2.422 to 3.794
SecondaryChange From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52

SBR in the putamen as measured by SPECT imaging of the dopamine transporter (DaT) with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · striatal binding ratio
Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52
striatal binding ratioPC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in Striatal Binding Ratio (SBR) in the Putamen as Measured by Single-Photon Emission Computed Tomography (SPECT) Imaging of the Dopamine Transporter (DaT) at Week 52-0.093 ± 0.0151-0.098 ± 0.0199-0.102 ± 0.0146-0.125 ± 0.0155
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.8274 · Difference: -0.005 · 95% CI -0.0548 to 0.0438
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.6671 · Difference: -0.009 · 95% CI -0.0504 to 0.0323
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.1313 · Difference: -0.033 · 95% CI -0.0751 to 0.0098
SecondaryChange From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52

SBR in the striatum as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · striatal binding ratio
Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52
striatal binding ratioPC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in SBR in the Striatum as Measured by SPECT Imaging of the DaT at Week 52-0.081 ± 0.0145-0.090 ± 0.0191-0.081 ± 0.0140-0.108 ± 0.0148
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.7079 · Difference: -0.009 · 95% CI -0.0562 to 0.0382
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.9835 · Difference: -0.000 · 95% CI -0.0400 to 0.0392
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.1869 · Difference: -0.027 · 95% CI -0.0682 to 0.0134
SecondaryChange From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52

SBR in the caudate as measured by SPECT imaging of the DaT with 123\^I-ioflupane (DaTscan™). The mean values reported are the adjusted mean values.

Time frame:
Baseline, Week 52
Reported as:
Mean · striatal binding ratio
Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52
striatal binding ratioPC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)
Change From Baseline in SBR in the Caudate as Measured by SPECT Imaging of the DaT at Week 52-0.067 ± 0.0166-0.075 ± 0.0219-0.060 ± 0.0161-0.089 ± 0.0171
Statistical analysis
  • PC Period: Placebo vs PC Period: BIIB054 250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.7585 · Difference: -0.008 · 95% CI -0.0625 to 0.0456
  • PC Period: Placebo vs PC Period: BIIB054 1250 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.7808 · Difference: 0.006 · 95% CI -0.0391 to 0.0520
  • PC Period: Placebo vs PC Period: BIIB054 3500 mg (Early Start) · Mixed Model for Repeated Measures · p = 0.3532 · Difference: -0.022 · 95% CI -0.0691 to 0.0248
SecondaryPercentage of Participants With Anti-BIIB054 Antibodies in the Serum
Time frame:
Up to Week 144
Reported as:
Number · percentage of participants
Percentage of Participants With Anti-BIIB054 Antibodies in the Serum
percentage of participantsPC Period: Placebo to BIIB054 250 mg/ 1250 mg / 3500 mg (Delayed Start - Pooled)PC Period: Early Start BIIB054 250 mgPC Period: Early Start BIIB054 1250 mgPC Period: Early Start BIIB054 3500 mg
Percentage of Participants With Anti-BIIB054 Antibodies in the Serum01.800

Adverse events

Collected over Up to 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PC Period: Placebo0/100 (0%)7/100 (7%)58/100 (58%)
PC Period: BIIB054 250 mg (Early Start)0/55 (0%)4/55 (7.3%)32/55 (58.2%)
PC Period: BIIB054 1250 mg (Early Start)0/102 (0%)4/102 (3.9%)61/102 (59.8%)
PC Period: BIIB054 3500 mg (Early Start)0/100 (0%)6/100 (6%)63/100 (63%)
DBE Period: Placebo to BIIB054 250 mg (Delayed Start)0/20 (0%)2/20 (10%)16/20 (80%)
DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)0/37 (0%)3/37 (8.1%)22/37 (59.5%)
DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)0/39 (0%)3/39 (7.7%)22/39 (56.4%)
DBE Period: BIIB054 250 mg (Early Start)0/52 (0%)3/52 (5.8%)25/52 (48.1%)
DBE Period: BIIB054 1250 mg (Early Start)0/100 (0%)5/100 (5%)51/100 (51%)
DBE Period: BIIB054 3500 mg (Early Start)1/94 (1.1%)7/94 (7.4%)56/94 (59.6%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventPC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)DBE Period: Placebo to BIIB054 250 mg (Delayed Start)DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)DBE Period: BIIB054 250 mg (Early Start)DBE Period: BIIB054 1250 mg (Early Start)DBE Period: BIIB054 3500 mg (Early Start)
BradycardiaCardiac disorders0/1000/550/1020/1001/200/370/390/520/1000/94
Transient ischaemic attackNervous system disorders0/1000/550/1021/1001/200/370/391/521/1000/94
Anaphylactic reactionImmune system disorders0/1000/550/1020/1000/201/370/390/520/1000/94
COVID-19Infections and infestations0/1000/550/1020/1000/201/370/390/520/1000/94
COVID-19 pneumoniaInfections and infestations0/1000/550/1020/1000/201/370/390/521/1000/94
Arthropod stingInjury, poisoning and procedural complications0/1000/550/1020/1000/201/370/390/520/1000/94
Invasive lobular breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1000/550/1020/1000/201/370/390/520/1000/94
OsteoarthritisMusculoskeletal and connective tissue disorders0/1000/550/1020/1000/200/371/390/521/1000/94
SpondylolisthesisMusculoskeletal and connective tissue disorders0/1000/550/1020/1000/200/371/390/520/1000/94
DepressionPsychiatric disorders0/1000/550/1021/1000/200/371/390/520/1000/94
Most frequent other events
Showing 10 of 56
Most frequent other events
EventPC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)DBE Period: Placebo to BIIB054 250 mg (Delayed Start)DBE Period: Placebo to BIIB054 1250 mg (Delayed Start)DBE Period: Placebo to BIIB054 3500 mg (Delayed Start)DBE Period: BIIB054 250 mg (Early Start)DBE Period: BIIB054 1250 mg (Early Start)DBE Period: BIIB054 3500 mg (Early Start)
HeadacheNervous system disorders18/1006/5519/10221/1003/205/375/391/527/10012/94
FallInjury, poisoning and procedural complications5/1005/556/10214/1002/202/373/3910/5216/10016/94
NasopharyngitisInfections and infestations12/10010/5510/10213/1002/200/370/392/524/1005/94
Back painMusculoskeletal and connective tissue disorders8/1003/558/10213/1000/204/376/395/525/1008/94
ArthralgiaMusculoskeletal and connective tissue disorders7/1005/559/10211/1001/204/373/393/527/1002/94
InsomniaPsychiatric disorders0/1000/550/1020/1000/204/372/393/522/1002/94
NauseaGastrointestinal disorders6/1001/556/1026/1001/202/374/392/524/1007/94
Urinary tract infectionInfections and infestations0/1000/550/1020/1002/202/371/393/522/1002/94
Procedural painInjury, poisoning and procedural complications0/1000/550/1020/1002/200/370/390/520/1001/94
DiarrhoeaGastrointestinal disorders4/1005/555/1026/1001/200/370/391/522/1003/94

Baseline characteristics

Intent-to-treat (ITT) population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo).

Age, Continuous
Age, Continuous(years)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Mean61.0 ± 8.3961.3 ± 9.2459.2 ± 8.4859.3 ± 9.9260.1 ± 9.01
Sex: Female, Male
Sex: Female, Male(Participants)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Female28162934107
Male72397366250
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Hispanic or Latino311611
Not Hispanic or Latino965410194345
Unknown or Not Reported10001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
American Indian or Alaska Native00022
Asian00336
Native Hawaiian or Other Pacific Islander00000
Black or African American00101
White96539284325
More than one race00000
Unknown or Not Reported4261123
Baseline Movement Disorder Society Sponsored Revision of the Unified PD Rating Scale Total Score
Baseline Movement Disorder Society Sponsored Revision of the Unified PD Rating Scale Total Score(score on a scale)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Mean31.9 ± 12.4131.9 ± 12.2532.9 ± 12.5832.6 ± 13.4632.4 ± 12.69
Baseline MDS-UPDRS Subpart I Score
Baseline MDS-UPDRS Subpart I Score(score on a scale)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Mean4.3 ± 3.503.3 ± 2.744.8 ± 3.994.3 ± 3.604.3 ± 3.59
Baseline MDS-UPDRS Subpart II Score
Baseline MDS-UPDRS Subpart II Score(score on a scale)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Mean5.4 ± 3.875.0 ± 3.305.3 ± 3.665.5 ± 4.305.3 ± 3.84
Baseline MDS-UPDRS Subpart III Score
Baseline MDS-UPDRS Subpart III Score(score on a scale)PC Period: PlaceboPC Period: BIIB054 250 mg (Early Start)PC Period: BIIB054 1250 mg (Early Start)PC Period: BIIB054 3500 mg (Early Start)Total
Mean22.2 ± 9.3123.5 ± 9.3822.8 ± 8.6922.9 ± 8.8622.8 ± 8.99

3 further baseline measures are reported on the registry.

07

Study locations

75 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • Research Site
    La Jolla, California 92093-0886, United States
  • Cedars Sinai
    Los Angeles, California 90048, United States
  • University of California San Francisco Medical Center
    San Francisco, California 94158, United States
  • Research Site
    Stanford, California 94305, United States
  • University of Colorado Health
    Aurora, Colorado 80045, United States
  • Rocky Mountain Movement Disorders Center, PC
    Englewood, Colorado 80113, United States
  • Parkinson's Disease and Movement Disorders Centerf
    Boca Raton, Florida 33486, United States
  • Mayo Clinic Hospital
    Jacksonville, Florida 32224, United States
  • Bioclinica Research
    Orlando, Florida 32806, United States
  • USF Health Byrd Institute
    Tampa, Florida 33616, United States
  • Northwestern University PD and Movement Disorders Center
    Chicago, Illinois 60611, United States
  • Research Site
    Chicago, Illinois 60612, United States
  • University of Kansas Medical Center Research Institute
    Kansas City, Kansas 66160, United States
  • Ochsner Health System
    New Orleans, Louisiana 70121, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Boston University Medical Center
    Boston, Massachusetts 02118, United States
  • Quest Research Institute
    Farmington Hills, Michigan 48334, United States
  • NYU Langone Health Center
    New York, New York 10017, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    Durham, North Carolina 27705, United States
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44106, United States
  • Research Site
    Philadelphia, Pennsylvania 19107, United States
  • University of Pittsburgh Medical Center Health System
    Pittsburgh, Pennsylvania 15213, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Research Site
    Nashville, Tennessee 37232, United States
  • Research Site
    Houston, Texas 77030, United States
  • Booth Gardner Parkinson's Care Center at Evergreen Health
    Kirkland, Washington 98034, United States
  • Inland Northwest Research
    Spokane, Washington 99204, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Research Site
    Innsbruck, 6020, Austria
  • University Health Network
    Toronto, Ontario M5T 2S8, Canada
  • Montreal Neurological Institute Clinical Research Unit
    Montréal, Quebec H3A 2B4, Canada
  • Research Name
    Toulouse Cedex 09, Haute Garonne 31059, France
  • CHU Nantes - Hopital Nord Laënnec
    Nantes, Loire Atlantique 44093, France
  • Hopital Roger Salengro - CHU Lille
    Lille Cedex, Nord 59037, France
  • Hôpital Henri Mondor
    Créteil, Val De Marne 94010, France
  • Research Site
    Paris, 75013, France
  • Universitaetsklinikum Ulm
    Ulm, Baden Wuerttemberg 89081, Germany
  • Klinikum rechts der Isar der TU Muenchen
    Muenchen, Bayern 81675, Germany
  • Universitaetsklinikum Wuerzburg
    Wuerzburg, Bayern 97080, Germany
  • Paracelsus-Elena-Klinik
    Kassel, Hessen 34128, Germany
  • Universitaetsklinikum Aachen AOeR
    Aachen, Nordrhein Westfalen 52074, Germany
  • Research Site
    Bochum, Nordrhein Westfalen 44791, Germany
  • Research Site
    Haifa, 3109601, Israel
  • Research Site
    Tel Aviv, 6423906, Israel
  • I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
    Pozzilli, Isernia 86077, Italy
  • Ospedale Bellaria
    Bologna, 40139, Italy
  • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
    Catania, 95125, Italy
  • Research Site
    Milano, 20122, Italy
  • Ospedale San Raffaele
    Milano, 20132, Italy
  • Research Site
    Milano, 20132, Italy
  • Seconda Università degli Studi di Napoli
    Napoli, 80138, Italy
  • Research Site
    Pisa, 56126, Italy
  • IRCCS San Raffaele
    Roma, 00163, Italy
  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
    Salerno, 84131, Italy
  • Azienda Ospedaliera Santa Maria di Terni
    Terni, 05100, Italy
  • Hospital General de Catalunya
    Sant Cugat del Vallés, Barcelona 08190, Spain
  • Research Site
    Móstoles, Madrid 28938, Spain
  • Clinica Universidad de Navarra
    Pamplona, Navarra 31008, Spain
  • Biocruces Health Research Institute
    Barakaldo, Vizcaya 48903, Spain
  • Hospital Clinic De Barcalona
    Barcelona, 08036, Spain
  • Hospital Santa Creu i Sant Pau
    Barcelona, 08041, Spain
  • Research Site
    Madrid, 28006, Spain
  • Research Site
    Madrid, 28007, Spain
  • Research Site
    Madrid, 28034, Spain
  • Research Site
    Sevilla, 41013, Spain
  • Research Site
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
  • Salford Royal
    Salford, Greater Manchester M6 8HD, United Kingdom
  • Research Site
    Oxford, Oxfordshire OX3 9DU, United Kingdom
  • Clinical Ageing Research Unit
    Newcastle upon Tyne, Tyne & Wear NE4 5PL, United Kingdom
  • Royal Hallamshire Hospital
    Sheffield, West Midlands S10 2JF, United Kingdom
  • Research Site
    London, WC1N 3BG, United Kingdom
08

References and documents

Publications

  • Lang AE, Siderowf AD, Macklin EA, Poewe W, Brooks DJ, Fernandez HH, Rascol O, Giladi N, Stocchi F, Tanner CM, Postuma RB, Simon DK, Tolosa E, Mollenhauer B, Cedarbaum JM, Fraser K, Xiao J, Evans KC, Graham DL, Sapir I, Inra J, Hutchison RM, Yang M, Fox T, Budd Haeberlein S, Dam T; SPARK Investigators. Trial of Cinpanemab in Early Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):408-420. doi: 10.1056/NEJMoa2203395. PubMed 35921450 ↗
  • Hutchison RM, Evans KC, Fox T, Yang M, Barakos J, Bedell BJ, Cedarbaum JM, Brys M, Siderowf A, Lang AE. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial. BMC Neurol. 2021 Nov 23;21(1):459. doi: 10.1186/s12883-021-02470-8. PubMed 34814867 ↗

Study documents

  • Study protocol · Aug 13, 2020
  • Statistical analysis plan · Jun 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

09

Registry details

Key details

Study ID
NCT03318523
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Oct 24, 2017
Start date
Jan 10, 2018
Primary completion
Oct 26, 2020
Completion
Apr 29, 2021
Results posted
Nov 23, 2021
Last update
Feb 28, 2022

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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