Trial · NCT04777331
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
NCT04777331, Phase 2, Active not recruiting, Hoffmann-La Roche; results first posted 2025-12-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease. Trials, record NCT04777331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04777331
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
- NCT number
- NCT04777331
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 586 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Parkinsons Disease
- Interventions
- Prasinezumab, Placebo
- First posted
- 2021-03-02
- Last updated
- 2026-09-04
- Other registries' IDs
- eudract:2020-004997-23
- Results first posted
- 2025-12-02
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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). |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | DBT Period: Placebo | 49.7 | 95% Confidence Interval 40.1 to 58.1 | weeks | |
| DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | DBT Period: Prasinezumab | 61.1 | 95% Confidence Interval 52.3 to 71.9 | 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 | DBT Period: Placebo | 88.3 | 95% Confidence Interval 62.7 to 105.1 | 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 | DBT Period: Prasinezumab | 112.1 | 95% Confidence Interval 81.1 to NA | weeks | |
| DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale | DBT Period: Placebo | 36.1 | 95% Confidence Interval 29.9 to 42.1 | weeks | |
| DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale | DBT Period: Prasinezumab | 44.4 | 95% Confidence Interval 38.1 to 52.1 | weeks | |
| DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale | DBT Period: Placebo | 52.1 | 95% Confidence Interval 44.1 to 59.9 | weeks | |
| DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale | DBT Period: Prasinezumab | 60.6 | 95% Confidence Interval 56.1 to 67.3 | weeks | |
| DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV | DBT Period: Placebo | 91.1 | 95% Confidence Interval 77.0 to 107.6 | weeks | |
| DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV | DBT Period: Prasinezumab | 100.1 | 95% Confidence Interval 81.0 to 117.1 | weeks |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DBT Period | STARTED | DBT Period: Placebo | 293 | |
| DBT Period | STARTED | DBT Period: Prasinezumab | 293 | |
| DBT Period | STARTED | OLE Period: Prasinezumab | 0 | |
| DBT Period | Safety Analysis Set (SAS) | DBT Period: Placebo | 290 | |
| DBT Period | Safety Analysis Set (SAS) | DBT Period: Prasinezumab | 292 | |
| DBT Period | Safety Analysis Set (SAS) | OLE Period: Prasinezumab | 0 | |
| DBT Period | COMPLETED | DBT Period: Placebo | 273 | |
| DBT Period | COMPLETED | DBT Period: Prasinezumab | 277 | |
| DBT Period | COMPLETED | OLE Period: Prasinezumab | 0 | |
| DBT Period | NOT COMPLETED | DBT Period: Placebo | 20 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | DBT Period: Placebo | 15 | 290 | 16 |
| other | Constipation | Gastrointestinal disorders | DBT Period: Prasinezumab | 19 | 292 | 26 |
| other | Diarrhoea | Gastrointestinal disorders | DBT Period: Placebo | 13 | 290 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | DBT Period: Prasinezumab | 15 | 292 | 21 |
| other | Fatigue | General disorders | DBT Period: Placebo | 11 | 290 | 11 |
| other | Fatigue | General disorders | DBT Period: Prasinezumab | 21 | 292 | 23 |
| other | COVID-19 | Infections and infestations | DBT Period: Placebo | 68 | 290 | 77 |
| other | COVID-19 | Infections and infestations | DBT Period: Prasinezumab | 84 | 292 | 96 |
| other | Influenza | Infections and infestations | DBT Period: Placebo | 16 | 290 | 16 |
| other | Influenza | Infections and infestations | DBT Period: Prasinezumab | 21 | 292 | 23 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DBT Period: Placebo | 2 | 290 |
| Total, all-cause mortality | DBT Period: Prasinezumab | 1 | 292 |
| Total, other adverse events | DBT Period: Placebo | 205 | 290 |
| Total, other adverse events | DBT Period: Prasinezumab | 206 | 292 |
| Total, serious adverse events | DBT Period: Placebo | 34 | 290 |
| Total, serious adverse events | DBT Period: Prasinezumab | 34 | 292 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42208564 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Infusion Related Reactions (IRRs) | Trial comparisons |
| DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Treatment Discontinuation Due to AEs | Trial comparisons |
| DBT Period: Prasinezumab vs DBT Period: Placebo: DBT Period: Number of Participants With Adverse Events of Special Interest (AESI) | Trial comparisons |
| DBT Period: Prasinezumab vs DBT Period: Placebo: deaths from any cause | Trial comparisons |
| DBT Period: Prasinezumab vs DBT Period: Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04777331
GET https://conductscience.org/api/trials/v1/NCT04777331/results?page=2