Trial · NCT04777331
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | From study start to end of DBT period to at least 76 weeks | FAS included all randomized participants, with participants grouped according to their randomized treatment. | weeks | MEDIAN |
| SECONDARY | DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event | From study start to end of DBT period to at least 76 weeks | FAS included all randomized participants, with participants grouped according to their randomized treatment. | weeks | MEDIAN |
| SECONDARY | DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale | From study start to end of DBT period to at least 76 weeks | FAS included all randomized participants, with participants grouped according to their randomized treatment. | weeks | MEDIAN |
| SECONDARY | DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale | From study start to end of DBT period to at least 76 weeks | FAS included all randomized participants, with participants grouped according to their randomized treatment. | weeks | MEDIAN |
| SECONDARY | DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV | From study start to end of DBT period to at least 76 weeks | FAS included all randomized participants, with participants grouped according to their randomized treatment. | weeks | MEDIAN |
| SECONDARY | DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score | From baseline up to Week 76 | FAS included all randomized participants, with participants grouped according to their randomized treatment. Overall number analyzed is the number of participants with data available for analysis. | Units on a scale | MEAN |
| SECONDARY | DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore | From baseline up to Week 76 | FAS included all randomized participants, with participants grouped according to their randomized treatment. Overall number analyzed is the number of participants with data available for analysis. | Units on a scale | MEAN |
| SECONDARY | DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From study start to end of DBT period to at least 76 weeks | Safety Analysis Set (SAS) included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Adverse Events of Special Interest (AESI) | From study start to end of DBT period to at least 76 weeks | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Treatment Discontinuation Due to AEs | From study start to end of DBT period to at least 76 weeks | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With Infusion Related Reactions (IRRs) | From study start to end of DBT period to at least 76 weeks | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | From study start to end of DBT period to at least 76 weeks | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 | Pharmacokinetic (PK) Analysis Set (PAS) included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration. | micrograms/milliliter (µg/mL) | MEDIAN |
| SECONDARY | DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 | PAS included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration. | µg/mL | MEDIAN |
| SECONDARY | DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 | PAS included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration. | hours*microgram/milliter (h*µg/mL) | MEDIAN |
| SECONDARY | DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment | From study start to end of DBT period to at least 76 weeks | Immunogenicity population included all participants on active treatment with at least one ADA assessment. Percentages have been rounded off. | percentage of participants | NUMBER |
| SECONDARY | OLE Period: Number of Participants With AEs and SAEs | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | |||
| SECONDARY | OLE Period: Number of Participants With AESI | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | |||
| SECONDARY | OLE Period: Number of Participants With IRRs | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | |||
| SECONDARY | OLE Period: Number of Participants With in Suicidal Ideation, as Measured by the C-SSRS | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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