A Phase 2 interventional study of Prasinezumab and Placebo in Parkinsons Disease, sponsored by Hoffmann-La Roche. Active, not recruiting at 110 sites in 9 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
Exclusion Criteria:
Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.
Drug: Prasinezumab
Participants will receive placebo as an IV infusion Q4W.
Drug: Placebo
Prasinezumab will be administered as an IV infusion to participants Q4W.
Prasinezumab placebo will be administered to participants.
DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event
Time to worsening of the motor function was defined as ≥3 points increase in MDS-UPDRS Part II score from baseline in the presence of a confirmed motor progression event. For the confirmed motor progression event the definition is as per primary endpoint definition. MDS-UPDRS Part II assesses motor experiences of daily living \& contained 13 questions answered by participant. For each question a numeric score is assigned between 0-4, 0 = Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Score range: 0 to 52 with higher score=severe impairment.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale
The PGI is a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (PGI-C) was intended to measure health state changes as reported by the participant on a 7-point scale (1=Very much improved to 7=Very much worse). The meaningfulness of the change was assessed and reported by the participant.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale
The CGI was a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (CGI-C) was intended to measure health state changes as reported by the clinician on a 7-point scale (1=Very much improved to 7=Very much worse).
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV
MDS-UPDRS Part IV assessed motor complications of symptomatic treatment, dyskinesias, and motor fluctuations. The rater completed this assessment only for participants on L-Dopa treatment.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score
MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
Time frame: From baseline up to Week 76
DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore
MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. For bradykinesia, subscore ranges from 0 to 52, while rigidity subscore ranges from 0 to 20, with higher scores indicating greater impairment. Change in bradykinesia and rigidity was assessed in "OFF" medication state. Adjusted mean is reported here.
Time frame: From baseline up to Week 76
DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. Number of participants with atleast 1 AE and SAE are reported here.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With Adverse Events of Special Interest (AESI)
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \& aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With Treatment Discontinuation Due to AEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With Infusion Related Reactions (IRRs)
IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
Time frame: From study start to end of DBT period to at least 76 weeks
DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS)
Time frame: Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76
DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS)
Time frame: Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76
DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS)
Time frame: Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76
DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment
Time frame: From study start to end of DBT period to at least 76 weeks
OLE Period: Number of Participants With AEs and SAEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Time frame: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
OLE Period: Number of Participants With AESI
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated ALT \& AST in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.
Time frame: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
OLE Period: Number of Participants With IRRs
IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.
Time frame: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
OLE Period: Number of Participants With in Suicidal Ideation, as Measured by the C-SSRS
C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior.
Time frame: From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
A total of 586 participants with early-stage Parkinson's disease (PD) took part in the study across 110 investigative sites in 9 countries. The study consisted of double-blind treatment (DBT), where participants were randomized in 1:1 ratio to receive prasinezumab or placebo and an optional open-label extension (OLE).
| Milestone | DBT Period: Placebo | DBT Period: Prasinezumab | OLE Period: Prasinezumab |
|---|---|---|---|
| Started | 293 | 293 | 0 |
| Safety analysis set (sas) | 290 | 292 | 0 |
| Completed | 273 | 277 | 0 |
| Not completed | 20 | 16 | 0 |
| Withdrew: Death | 2 | 1 | 0 |
| Withdrew: Reason not specified | 1 | 1 | 0 |
| Withdrew: Physician decision | 4 | 0 | 0 |
| Withdrew: Withdrawal by subject | 12 | 11 | 0 |
| Withdrew: Randomized but not treated | 1 | 3 | 0 |
| Milestone | DBT Period: Placebo | DBT Period: Prasinezumab | OLE Period: Prasinezumab |
|---|---|---|---|
| Started | 0 | 0 | 534 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 534 |
| Withdrew: Ongoing in ole | 0 | 0 | 534 |
Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
| weeks | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 49.7 (40.1 to 58.1) | 61.1 (52.3 to 71.9) |
Time to worsening of the motor function was defined as ≥3 points increase in MDS-UPDRS Part II score from baseline in the presence of a confirmed motor progression event. For the confirmed motor progression event the definition is as per primary endpoint definition. MDS-UPDRS Part II assesses motor experiences of daily living \& contained 13 questions answered by participant. For each question a numeric score is assigned between 0-4, 0 = Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Score range: 0 to 52 with higher score=severe impairment.
| weeks | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event | 88.3 (62.7 to 105.1) | 112.1 (81.1 to NA) |
The PGI is a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (PGI-C) was intended to measure health state changes as reported by the participant on a 7-point scale (1=Very much improved to 7=Very much worse). The meaningfulness of the change was assessed and reported by the participant.
| weeks | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale | 36.1 (29.9 to 42.1) | 44.4 (38.1 to 52.1) |
The CGI was a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (CGI-C) was intended to measure health state changes as reported by the clinician on a 7-point scale (1=Very much improved to 7=Very much worse).
| weeks | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale | 52.1 (44.1 to 59.9) | 60.6 (56.1 to 67.3) |
MDS-UPDRS Part IV assessed motor complications of symptomatic treatment, dyskinesias, and motor fluctuations. The rater completed this assessment only for participants on L-Dopa treatment.
| weeks | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV | 91.1 (77.0 to 107.6) | 100.1 (81.0 to 117.1) |
MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
| Units on a scale | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score | 4.00 ± 0.592 | 3.61 ± 0.597 |
MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. For bradykinesia, subscore ranges from 0 to 52, while rigidity subscore ranges from 0 to 20, with higher scores indicating greater impairment. Change in bradykinesia and rigidity was assessed in "OFF" medication state. Adjusted mean is reported here.
| Units on a scale | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore | 2.77 ± 0.476 | 2.85 ± 0.479 |
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. Number of participants with atleast 1 AE and SAE are reported here.
| Participants | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| AEs | 260 | 267 |
| SAEs | 34 | 34 |
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) \& aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.
| Participants | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Number of Participants With Adverse Events of Special Interest (AESI) | 0 | 0 |
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
| Participants | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Number of Participants With Treatment Discontinuation Due to AEs | 3 | 2 |
IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.
| Participants | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| DBT Period: Number of Participants With Infusion Related Reactions (IRRs) | 37 | 32 |
C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
| Participants | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| Passive: Wish to be Dead | 6 | 5 |
| Non-specific Active Suicidal Thoughts | 2 | 2 |
| Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act | 3 | 0 |
| Self-injurious Behavior, no Suicidal Intent | 0 | 1 |
| micrograms/milliliter (µg/mL) | DBT Period: Prasinezumab |
|---|---|
| DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS) | 313.5 (217.3 to 514.9) |
| µg/mL | DBT Period: Prasinezumab |
|---|---|
| DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS) | 28.7 (12.1 to 60.9) |
| hours*microgram/milliter (h*µg/mL) | DBT Period: Prasinezumab |
|---|---|
| DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS) | 49384 (34850 to 82330) |
| percentage of participants | DBT Period: Prasinezumab |
|---|---|
| DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment | 0.3 |
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Results for this outcome have not been posted.
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated ALT \& AST in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.
Results for this outcome have not been posted.
IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.
Results for this outcome have not been posted.
C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior.
Results for this outcome have not been posted.
Collected over From study start until the end of DBT period for at least 76 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DBT Period: Placebo | 2/290 (0.7%) | 34/290 (11.7%) | 205/290 (70.7%) |
| DBT Period: Prasinezumab | 1/292 (0.3%) | 34/292 (11.6%) | 206/292 (70.5%) |
| Event | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| Acute myocardial infarctionCardiac disorders | 1/290 | 4/292 |
| Inguinal herniaGastrointestinal disorders | 3/290 | 2/292 |
| Urinary tract infectionInfections and infestations | 0/290 | 3/292 |
| Back painMusculoskeletal and connective tissue disorders | 2/290 | 0/292 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/290 | 0/292 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/290 | 1/292 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/290 | 0/292 |
| FallInjury, poisoning and procedural complications | 0/290 | 2/292 |
| Femur fractureInjury, poisoning and procedural complications | 1/290 | 2/292 |
| AnaemiaBlood and lymphatic system disorders | 1/290 | 0/292 |
| Event | DBT Period: Placebo | DBT Period: Prasinezumab |
|---|---|---|
| COVID-19Infections and infestations | 68/290 | 84/292 |
| Back painMusculoskeletal and connective tissue disorders | 40/290 | 46/292 |
| Infusion related reactionInjury, poisoning and procedural complications | 36/290 | 31/292 |
| NasopharyngitisInfections and infestations | 31/290 | 36/292 |
| FallInjury, poisoning and procedural complications | 30/290 | 34/292 |
| Urinary tract infectionInfections and infestations | 32/290 | 24/292 |
| HeadacheNervous system disorders | 18/290 | 27/292 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 25/290 | 26/292 |
| FatigueGeneral disorders | 11/290 | 21/292 |
| InfluenzaInfections and infestations | 16/290 | 21/292 |
Full Analysis Set (FAS) included all randomized participants, with participants grouped according to their randomized treatment.
| Age, Continuous(years) | DBT Period: Placebo | DBT Period: Prasinezumab | Total |
|---|---|---|---|
| Mean | 64.4 ± 7.5 | 64.0 ± 7.2 | 64.2 ± 7.3 |
| Sex: Female, Male(Participants) | DBT Period: Placebo | DBT Period: Prasinezumab | Total |
|---|---|---|---|
| Female | 104 | 110 | 214 |
| Male | 189 | 183 | 372 |
| Ethnicity (NIH/OMB)(Participants) | DBT Period: Placebo | DBT Period: Prasinezumab | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 33 | 64 |
| Not Hispanic or Latino | 246 | 241 | 487 |
| Unknown or Not Reported | 16 | 19 | 35 |
| Race (NIH/OMB)(Participants) | DBT Period: Placebo | DBT Period: Prasinezumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 278 | 275 | 553 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 14 | 25 |
Showing the first 100 of 110 sites across 9 countries.
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