Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

NCT05819359 · View on ClinicalTrials.gov ↗

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

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

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bial R&D Investments, S.A., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05819359 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Maryland, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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