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CompletedNCT02728843SKYUpdated Apr 10, 2024Results posted

Study of Parkinson's Early Stage With Deferiprone

A Phase 2 interventional study of Deferiprone and Placebo in Parkinson's Disease, sponsored by ApoPharma. Completed at 20 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by ApoPharma (part of Chiesi Farmaceutici S.p.A.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

Read the detailed description

This study will enroll 140 patients who have been diagnosed with Parkinson's disease within the last 3 years and are currently taking antiparkinsonian medication. There are four dosage cohorts, with patients in each cohort receiving either deferiprone tablets or placebo. At the baseline visit, participants will be randomized to a dosage cohort and to either active product or placebo within that cohort, and will take the assigned study product twice-daily for 9 months. They will come back to the study site for assessments at Months 1, 2, 3, 4, 5, 6, and 9, and will need to have their blood count checked weekly, at either the study site or a local laboratory.

02

Conditions studied

  • Parkinson's Disease

Browse trials for

Keywords

  • Parkinson's disease
  • Deferiprone
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's enrollment of 140 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

ApoPharma is the lead sponsor of 23 studies on the registry; none are open to participants now.

Browse ApoPharma studies →All Chiesi Farmaceutici S.p.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female aged ≥18 to \< 80 years
  • Body weight ≥60 kg but ≤100 kg
  • Parkinson's disease diagnosed
  • (ANC) ≥1.5 x 10\^9/L (≥1.0 x 10\^9/L for Black population) at screening
  • On a stable dose for at least 3 months prior to the screening visit of any of the following treatments at an L-dopa equivalent daily dose of up to 600 mg:
  • Dopaminergic agonist alone
  • L-dopa alone
  • Combination therapy with dopaminergic agonist and L-dopa
  • Rasagiline
  • At an early stage of the disease, without motor fluctuations and/or L-dopa-induced dyskinesia

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of Parkinson's disease more than 3 years prior to screening visit
  • Hoehn and Yahr stage ≥ 3
  • Atypical or secondary Parkinsonism without dopa-sensitivity (e.g., vascular parkinsonism, supranuclear palsy, multisystem atrophy)
  • Progressing Axis I psychiatric disorders (psychosis, hallucinations, compulsive disorders, substance addiction, bipolar disorder, severe depression, anxiety) as assessed in a semi-structured interview in accordance with the
  • Not stabilized in terms of the current antiparkinsonian therapeutic regimen: already requires dose adaptation and/or is likely to require any change in dopamine therapy over the duration of the trial
  • Current treatment with bromocriptine
  • Current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria
  • Current treatment with coenzyme Q10 or idebenone. (Patients who are on these medications but stop taking them at least 2 weeks prior to baseline may be enrolled.)
  • Current use of a Deep Brain Stimulation (DBS) system. (Patients who previously had a DBS system but have had it removed may be enrolled.)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

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

Study arms

  • Experimental
    Deferiprone 300 mg

    One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg

    Drug: Deferiprone

  • Experimental
    Deferiprone 600 mg

    One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg

    Drug: Deferiprone

  • Experimental
    Deferiprone 900 mg

    One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg

    Drug: Deferiprone

  • Experimental
    Deferiprone 1200 mg

    Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg

    Drug: Deferiprone

  • Placebo comparator
    Placebo

    Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day

    Drug: Placebo

Interventions

  • DrugDeferiprone

    600 mg tablets

    Also known as: DFP

  • DrugPlacebo

    Tablets that match the deferiprone tablets in appearance

06

What researchers measure

Primary outcomes

  1. Change in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Change from baseline to Month 9 in the score for the Part III subscale (motor examination) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 132 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

    Time frame: Nine months

Secondary outcomes

  1. Change in Total Score on the MDS-UPDRS

    Change from baseline to Month 9 in total score on the MDS-UPDRS. The total score can range from 0 (best) to 260 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

    Time frame: Nine months

  2. Change in Score on the Part I Subscale of the MDS-UPDRS

    Change from baseline to Month 9 in the score for the Part I subscale (mentation, behavior, and mood) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

    Time frame: Nine months

  3. Change in Score on the Part II Subscale of the MDS-UPDRS

    Change from baseline to Month 9 in the score for the Part II subscale (activities of daily living) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

    Time frame: Nine months

  4. Change in Score in the Part IV Subscale of the MDS-UPDRS

    Change from baseline to Month 9 in the score for the Part IV subscale (motor complications) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 24 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

    Time frame: Nine months

  5. Change in the Combined Scores From Parts II and III of the MDS-UPDRS

    Change from baseline to Month 9 in the combined score for the Part II subscale (motor experiences of daily living) and the Part III subscale (motor examination) of the MDS-UPDRS. The scales for these two parts range from 0 (best) to 52 (worst) and from 0 (best) to 132 (worst), respectively. Hence, the combined score can range from 0 (best) to 184 (worst), and an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score is presented as least square means.

    Time frame: Nine months

  6. Change in Score on the Montreal Cognitive Assessment (MoCA) Test

    Change from baseline to Month 9 in the score for overall cognitive function as assessed by the MoCA. The total score on the MoCA can range from 0 (worst) to 30 (best). Hence, a decrease in score would indicate progression of the disease and an increase would indicate improvement. The change in score is presented as least square means.

    Time frame: Nine months

  7. Safety of Deferiprone

    Number of subjects with adverse events

    Time frame: Nine months

  8. Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

    Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The maximum measured serum concentration (Cmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.

    Time frame: 4 hours

  9. Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

    Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The time to maximum observed serum concentration (Tmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.

    Time frame: 4 hours

  10. Area Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide

    Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The total drug exposure, AUC0-∞ (area under the serum concentration time curve extrapolated to infinity) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.

    Time frame: 4 hours

07

Results

Posted Apr 10, 2024

Participant flow

Participant flow — Overall Study
MilestonePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Started2828282828
Completed2523202223
Not completed35865
Withdrew: Adverse event02312
Withdrew: Lack of efficacy01100
Withdrew: Protocol violation20422
Withdrew: Withdrawal by subject10010
Withdrew: Use of rescue medication02021

Outcome measures

PrimaryChange in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Change from baseline to Month 9 in the score for the Part III subscale (motor examination) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 132 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)2.1 ± 1.44.2 ± 1.4-0.8 ± 1.53.9 ± 1.52.2 ± 1.4
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 900 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondaryChange in Total Score on the MDS-UPDRS

Change from baseline to Month 9 in total score on the MDS-UPDRS. The total score can range from 0 (best) to 260 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in Total Score on the MDS-UPDRS
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in Total Score on the MDS-UPDRS4.1 ± 1.97.8 ± 1.90.5 ± 2.16.6 ± 2.15.9 ± 2.0
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 900 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondaryChange in Score on the Part I Subscale of the MDS-UPDRS

Change from baseline to Month 9 in the score for the Part I subscale (mentation, behavior, and mood) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in Score on the Part I Subscale of the MDS-UPDRS
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in Score on the Part I Subscale of the MDS-UPDRS0.8 ± 0.71.0 ± 0.70.3 ± 0.70.3 ± 0.71.1 ± 0.7
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 900 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondaryChange in Score on the Part II Subscale of the MDS-UPDRS

Change from baseline to Month 9 in the score for the Part II subscale (activities of daily living) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in Score on the Part II Subscale of the MDS-UPDRS
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in Score on the Part II Subscale of the MDS-UPDRS1.1 ± 0.62.2 ± 0.60.6 ± 0.62.1 ± 0.61.8 ± 0.6
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondaryChange in Score in the Part IV Subscale of the MDS-UPDRS

Change from baseline to Month 9 in the score for the Part IV subscale (motor complications) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 24 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in Score in the Part IV Subscale of the MDS-UPDRS
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in Score in the Part IV Subscale of the MDS-UPDRS-0.1 ± 0.20.2 ± 0.20.3 ± 0.20.2 ± 0.20.4 ± 0.2
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 900 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondaryChange in the Combined Scores From Parts II and III of the MDS-UPDRS

Change from baseline to Month 9 in the combined score for the Part II subscale (motor experiences of daily living) and the Part III subscale (motor examination) of the MDS-UPDRS. The scales for these two parts range from 0 (best) to 52 (worst) and from 0 (best) to 132 (worst), respectively. Hence, the combined score can range from 0 (best) to 184 (worst), and an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score is presented as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in the Combined Scores From Parts II and III of the MDS-UPDRS
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in the Combined Scores From Parts II and III of the MDS-UPDRS3.3 ± 1.66.5 ± 1.6-0.3 ± 1.76.0 ± 1.74.3 ± 1.7
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 900 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondaryChange in Score on the Montreal Cognitive Assessment (MoCA) Test

Change from baseline to Month 9 in the score for overall cognitive function as assessed by the MoCA. The total score on the MoCA can range from 0 (worst) to 30 (best). Hence, a decrease in score would indicate progression of the disease and an increase would indicate improvement. The change in score is presented as least square means.

Time frame:
Nine months
Reported as:
Least squares mean · Score on a scale
Change in Score on the Montreal Cognitive Assessment (MoCA) Test
Score on a scalePlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Change in Score on the Montreal Cognitive Assessment (MoCA) Test1.1 ± 0.31.0 ± 0.30.9 ± 0.31.1 ± 0.31.4 ± 0.3
Statistical analysis
  • Placebo vs Deferiprone 300 mg vs Deferiprone 600 mg vs Deferiprone 900 mg vs Deferiprone 1200 mg · ANCOVA · p = >0.05
SecondarySafety of Deferiprone

Number of subjects with adverse events

Time frame:
Nine months
Reported as:
Count of participants · Participants
Safety of Deferiprone
ParticipantsPlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
Safety of Deferiprone2625232525
SecondaryCmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The maximum measured serum concentration (Cmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.

Time frame:
4 hours
Reported as:
Mean · μg/mL
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
μg/mL300 mg600 mg900 mg1200 mg
Serum deferiprone2.748 ± 0.7813.459 ± 0.0785.080 ± 2.6147.942 ± 2.192
Serum deferiprone 3-O-glucuronide7.844 ± 0.93612.419 ± 2.21821.914 ± 8.30932.632 ± 2.167
SecondaryTmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The time to maximum observed serum concentration (Tmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.

Time frame:
4 hours
Reported as:
Median · Hours
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hours300 mg600 mg900 mg1200 mg
Serum deferiprone2.00 (1.67 to 2.33)2.17 (2.00 to 2.33)2.00 (0.58 to 2.67)1.67 (1.33 to 2.00)
Serum deferiprone 3-O-glucuronide2.84 (2.33 to 3.00)3.25 (3.00 to 3.50)3.50 (2.67 to 3.58)2.50 (2.33 to 2.67)
SecondaryArea Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide

Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The total drug exposure, AUC0-∞ (area under the serum concentration time curve extrapolated to infinity) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide.

Time frame:
4 hours
Reported as:
Mean · μg*h/mL
Area Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide
μg*h/mL300 mg600 mg900 mg1200 mg
Serum deferiprone8.358 ± 0.90416.29220.606 ± 8.74226.328 ± 5.693
Serum deferiprone 3-O-glucuronide39.057 ± 7.82062.679121.128 ± 43.727147.397 ± 6.502

Adverse events

Collected over 10 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/28 (0%)2/28 (7.1%)26/28 (92.9%)
Deferiprone 300 mg0/28 (0%)1/28 (3.6%)25/28 (89.3%)
Deferiprone 600 mg0/28 (0%)3/28 (10.7%)23/28 (82.1%)
Deferiprone 900 mg0/28 (0%)4/28 (14.3%)25/28 (89.3%)
Deferiprone 1200 mg0/28 (0%)1/28 (3.6%)25/28 (89.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
NeutropeniaBlood and lymphatic system disorders0/280/281/281/281/28
Atrial fibrillationCardiac disorders1/280/280/281/280/28
Head injuryInjury, poisoning and procedural complications0/280/281/280/280/28
Renal cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/281/280/280/280/28
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/280/280/281/280/28
Jealous delusionPsychiatric disorders1/280/280/280/280/28
Renal colicRenal and urinary disorders0/280/280/281/280/28
Renal impairmentRenal and urinary disorders0/280/280/281/280/28
Intermittent claudicationVascular disorders0/280/281/280/280/28
Most frequent other events
Showing 10 of 47
Most frequent other events
EventPlaceboDeferiprone 300 mgDeferiprone 600 mgDeferiprone 900 mgDeferiprone 1200 mg
HeadacheNervous system disorders2/286/284/285/288/28
DiarrhoeaGastrointestinal disorders3/282/281/282/287/28
Condition aggravatedGeneral disorders1/285/282/286/284/28
TremorNervous system disorders1/283/282/286/282/28
NauseaGastrointestinal disorders1/284/285/282/285/28
NasopharyngitisInfections and infestations1/283/282/285/284/28
ToothacheGastrointestinal disorders0/284/280/281/281/28
FatigueGeneral disorders2/280/281/281/284/28
Back painMusculoskeletal and connective tissue disorders2/282/283/283/284/28
Muscle spasmsMusculoskeletal and connective tissue disorders0/284/281/280/282/28

Baseline characteristics

Only patients in the Intent to Treat (ITT) population are presented. The ITT population was defined as all randomized patients who received at least one dose of study drug and had a baseline and at least one post-baseline efficacy assessment for the primary endpoint.

Age, Continuous
Age, Continuous(years)300 mg600 mg900 mg1200 mgPlaceboTotal
Mean61.5 ± 8.763.2 ± 8.559.8 ± 10.260.3 ± 8.761.9 ± 9.261.4 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)300 mg600 mg900 mg1200 mgPlaceboTotal
Female106615643
Male172019132190
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)300 mg600 mg900 mg1200 mgPlaceboTotal
Hispanic or Latino100113
Not Hispanic or Latino2626252626129
Unknown or Not Reported000101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)300 mg600 mg900 mg1200 mgPlaceboTotal
American Indian or Alaska Native000000
Asian000101
Native Hawaiian or Other Pacific Islander000000
Black or African American000000
White2725252627130
More than one race010001
Unknown or Not Reported000101
Region of Enrollment
Region of Enrollment(participants)300 mg600 mg900 mg1200 mgPlaceboTotal
Canada001113
United Kingdom6436625
France171918211893
Germany4330212
MDS-UPDRS Total Score
MDS-UPDRS Total Score(units on a scale)300 mg600 mg900 mg1200 mgPlaceboTotal
Mean29.7 ± 11.631.1 ± 13.329.8 ± 12.324.5 ± 10.727.4 ± 12.328.4 ± 12.1
MDS-UPDRS Part I
MDS-UPDRS Part I(units on a scale)300 mg600 mg900 mg1200 mgPlaceboTotal
Mean6.2 ± 4.15.7 ± 3.05.9 ± 3.45.3 ± 2.45.0 ± 3.15.6 ± 3.2
MDS-UPDRS Part II
MDS-UPDRS Part II(units on a scale)300 mg600 mg900 mg1200 mgPlaceboTotal
Mean4.1 ± 3.55.8 ± 3.95.7 ± 5.03.9 ± 3.16.1 ± 4.05.1 ± 4.0

4 further baseline measures are reported on the registry.

08

Study locations

20 sites
  • Toronto Western Hospital
    Toronto, Ontario, Canada
  • CHU de Bordeaux, Centre Expert Parkinson
    Bordeaux, France
  • Hôpital Henri Mondor
    Creteil, France
  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro
    Lille, France
  • CHU Dupuytren
    Limoges, France
  • Hôpital Neurologique Pierre Wertheimer
    Lyon, France
  • CHRU de Montpellier - Hôpital Gui de Chauliac
    Montpellier, France
  • CHU Pontchaillou
    Rennes, France
  • CHU Charles Nicoll - Rouen
    Rouen, France
  • Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre
    Strasbourg, France
  • CHU Purpan, Hôpital Pierre Paul Riquet
    Toulouse, France
  • Heinriche-Heine Universität Düsseldorf
    Dusseldorf, Germany
  • UKSH Campus Kiel, Neurologie
    Kiel, Germany
  • Universitätsklinikum Gießen und Marburg GmbH
    Marburg, Germany
  • Klinikum rechts der Isar
    Munich, Germany
  • Royal Devon & Exeter Hospital
    Exeter, Devon, United Kingdom
  • Fairfield General Hospital
    Bury, United Kingdom
  • Charing Cross Hospital
    London, United Kingdom
  • Newcastle Clinical Ageing Research Unit
    Newcastle Upon Tyne, United Kingdom
  • Derriford Hospital
    Plymouth, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Aug 2019, 33 months.

Results were first posted in Apr 2024, 4 years 8 months after primary completion.

Of 96 industry-sponsored phase 2 interventional studies under Parkinson Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 33. This study's 33 months is above that.

Counting every sponsor, half of 201 studies reached it within 28 months; a quarter within 16 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2016
First posted
Apr 5, 2016
StartActual
Oct 12, 2016
Primary completionActual
Aug 2, 2019
CompletionActual
Sep 4, 2019
Results first posted
Apr 10, 2024
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02728843
Lead sponsor
ApoPharma
Responsible party
Sponsor
First posted
Apr 5, 2016
Start date
Oct 12, 2016
Primary completion
Aug 2, 2019
Completion
Sep 4, 2019
Results posted
Apr 10, 2024
Last update
Apr 10, 2024

Study contacts

David Devos, MD
principal investigator · Hospitalier Régional Universitaire de Lille

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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