Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02906020 · ClinicalTrials.gov registry record · Phase 2
A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 273
- Enrollment target
NCT02906020: Clinical Trial Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT02906020 is a Phase 2 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 273 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02906020, a Phase 2 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 273 participants
- Enrollment target
Study Summary
Primary Objectives: * Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants. * Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: * To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation. * To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation. Part 2: * To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo. * To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event
Interventions
- DRUG Placebo
- DRUG venglustat GZ/SAR402671
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2016-12-15 |
| Est. Completion | 2021-05-27 |
| Phase | Phase 2 |
Why NCT02906020 stopped before completion
NCT02906020 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02906020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02906020 about?
NCT02906020 is a clinical study titled "A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation". Primary Objectives: * Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other...
What is the current status of trial NCT02906020?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 273 participants. The study started on 2016-12-15. Estimated completion is 2021-05-27.
What interventions are being tested in trial NCT02906020?
The interventions under investigation include: Placebo (DRUG), venglustat GZ/SAR402671 (DRUG).
Who is sponsoring clinical trial NCT02906020?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02906020's enrollment target sits among peer trials
273 204th of 2000 higher than 1,797 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07229430 · 273 participants · NA
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
- NCT03808922 · 274 participants · Phase 3
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
- NCT04573504 · 274 participants · Phase 4
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
- NCT05289557 · 274 participants · Phase 3
The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI