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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 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 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 13 states.

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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).

Conditions Studied

Parkinson's Disease

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

FieldValue
Enrollment Target 237 participants
Start Date 2023-03-31
Est. Completion 2026-07-31
Phase Phase 2

Sponsor

Bial R&D Investments, S.A.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05819359

The ClinicalTrials.gov registry entry for NCT05819359 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (63% lower). The listed sponsor is Bial R&D Investments, S.A., which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.