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
Public ClinicalTrials.gov record NCT05206773. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, 12-month Phase 3 Study to Evaluate the Effect of Venglustat on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease Who Are Treatment-naïve or Untreated for at Least 6 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05206773
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 122 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2022 (Actual)
- Primary completion
- Dec 17, 2025 (Actual)
- Completion
- Jan 4, 2027 (Estimated)
- Last update posted
- Oct 13, 2026
2022 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama -The Kirklin Clinic- Site Number : 8400011 | Birmingham | Alabama | 35233 | — |
| David Geffen School of Medicine at UCLA- Site Number : 8400006 | Los Angeles | California | 90095 | — |
| University of California Irvine Medical Center- Site Number : 8400019 | Orange | California | 92868 | — |
| AdventHealth Orlando- Site Number : 8400008 | Orlando | Florida | 32803 | — |
| Emory University School of Medicine - Atlanta- Site Number : 8400010 | Atlanta | Georgia | 30322 | — |
| WMCHealth Advanced Physician Services- Site Number : 8400001 | Hawthorne | New York | 10532 | — |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400013 | Cincinnati | Ohio | 45229-3026 | — |
| UPMC Montefiore- Site Number : 8400009 | Pittsburgh | Pennsylvania | 15213 | — |
| Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400012 | Dallas | Texas | 75204 | — |
| University of Utah Health Hospital- Site Number : 8400005 | Salt Lake City | Utah | 84132 | — |
| Lysosomal and Rare Disorders Research and Treatment Center (LDRTC)- Site Number : 8400004 | Fairfax | Virginia | 22030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05206773, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05206773 live on ClinicalTrials.gov.