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NCT05819359 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD
A Phase 2 study of Parkinson's Disease, sponsored by Bial R&D Investments, S.A..
- Active
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
- 20
- Study locations
NCT05819359: Active Phase 2 study of Parkinson's Disease, sponsored by Bial R&D Investments, S.A..
NCT05819359 is a Phase 2 study of Parkinson's Disease that is active but no longer recruiting, run by Bial R&D Investments, S.A.. The registered enrollment target is 237 participants, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05819359, a Phase 2 study of Parkinson's Disease, is active but no longer recruiting, sponsored by Bial R&D Investments, S.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 237 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).
Primary Outcome
Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living, as assessed by ≥2-point increase from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and no improvement in the Motor Examination, as assessed by ≥0-point increase from baseline in MDS-UPDRS Part III score. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BIA 28-6156 10 mg
- DRUG BIA 28-6156 60 mg
Study Locations (20)
Florida
- Parkinson's Center and Movement Disorders of Boca Raton - Boca Raton
- University of Miami, Dept. of Neurology - Miami
- Renstar Medical Research - Ocala
Maryland
- University of Maryland Medical Center - Baltimore
- Baylor University Medical Center - Baltimore
- The Johns Hopkins University School of Medicine - Baltimore
California
- University of California San Diego - La Jolla
- Cedars-Sinai - Los Angeles
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Arizona
- Barrow Neurological Institute - Phoenix
Colorado
- University of Colorado - Aurora
Georgia
- Morehouse School of Medicine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2023-03-31 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What the registry record for NCT05819359 still lists
NCT05819359 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05819359 names 20 study sites across 13 states, led by Florida, Maryland, California.
Frequently Asked Questions
What is clinical trial NCT05819359 about?
NCT05819359 is a clinical study titled "Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD". The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA...
What is the current status of trial NCT05819359?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2023-03-31. Estimated completion is 2026-07-31.
What conditions does trial NCT05819359 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT05819359?
The interventions under investigation include: Placebo (DRUG), BIA 28-6156 10 mg (DRUG), BIA 28-6156 60 mg (DRUG).
Who is sponsoring clinical trial NCT05819359?
This trial is sponsored by Bial R&D Investments, S.A., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05819359 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05819359's enrollment target sits among peer trials
237 30th of 158 higher than 129 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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