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NCT03318523 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
A Phase 2 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 357
- Enrollment target
NCT03318523 is a Phase 2 study that was terminated before completion, run by Biogen. The registered enrollment target is 357 participants.
The verdict
NCT03318523, a Phase 2 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 357 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG BIIB054
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2018-01-10 |
| Est. Completion | 2021-04-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03318523
The ClinicalTrials.gov registry entry for NCT03318523 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03318523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03318523 about?
NCT03318523 is a clinical study titled "Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease". 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 s...
What is the current status of trial NCT03318523?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 357 participants. The study started on 2018-01-10. Estimated completion is 2021-04-29.
What interventions are being tested in trial NCT03318523?
The interventions under investigation include: Placebo (DRUG), BIIB054 (DRUG).
Who is sponsoring clinical trial NCT03318523?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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