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NCT05206773 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease
A Phase 3 study of Fabry Disease, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
- 20
- Study locations
NCT05206773: Active Phase 3 study of Fabry Disease, sponsored by Sanofi.
NCT05206773 is a Phase 3 study of Fabry Disease that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 122 participants, below the 539-participant average among 32 other Fabry Disease trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206773, a Phase 3 study of Fabry Disease, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo-controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6 months. * Study visits will take place approximately every 3 months. * The double-blind period will be followed by an open-label extension (OLE) during which participants who have completed the double-blind period will be treated with venglustat for an additional 12 months or until the Common Study End of Treatment Day (CSEOTD).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Venglustat (GZ402671)
Study Locations (20)
Other
- Fundacion Cori para la Investigación y Prevención del Cancer_Investigational Site Number: 0320002 - La Rioja
- Instituto de Investigaciones Clínicas Quilmes (IICQ) SRL_Investigational Site Number: 0320003 - Quilmes
- Investigational Site Number: 0400001 - Vienna
- Instituto de Genética e Erros Inatos do Metabolismo - IGEIM- Site Number : 0760002 - São Paulo
California
- UCLA Medical Center_Investigational Site Number: 8400006 - Los Angeles
- University of California Irvine Medical Center- Site Number : 8400019 - Orange
Ohio
- Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400013 - Cincinnati
- Cleveland Clinic Site Number : 8400016 - Cleveland
Alabama
- Nephrology Clinic at Kirklin Clinic of UAB Hospital_Investigational Site Number: 8400011 - Birmingham
Florida
- Advent Health Orlando_Investigational Site Number: 8400008 - Orlando
Georgia
- Emory Genetics- Site Number : 8400010 - Atlanta
New York
- Westchester Medical Center Healthcare Corporation- Site Number : 8400001 - Hawthorne
Pennsylvania
- Children's Hospital Of Pittsburgh- Site Number : 8400009 - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2027-01-04 |
| Phase | Phase 3 |
What the registry record for NCT05206773 still lists
NCT05206773 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 539-participant average among 32 other Fabry Disease trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05206773 names 20 study sites across 15 states, led by Other, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05206773 about?
NCT05206773 is a clinical study titled "A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease". This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo-controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6...
What is the current status of trial NCT05206773?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2022-03-11. Estimated completion is 2027-01-04.
What conditions does trial NCT05206773 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT05206773?
The interventions under investigation include: Placebo (DRUG), Venglustat (GZ402671) (DRUG).
Who is sponsoring clinical trial NCT05206773?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05206773 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05206773's enrollment target sits among peer trials
122 5th of 32 higher than 28 of 32 other Fabry Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fabry 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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