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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

Study acronym: PERIDOT
StatusActive, Not Recruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites reduced: 58 → 50 locations
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 12 entries
  2. Primary completion date changed from estimate of Dec 7, 2025 to Dec 17, 2025v35
  3. Primary endpoints revised (2)
    • Study completion date: Dec 2, 2026 to Jan 4, 2027
    • Secondary endpoints revised (12)
    v34
  4. Study description revisedv33
  5. Primary completion date: Nov 30, 2024 to Dec 7, 2025v32 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 114 to confirmed 122
    • Study sites: 59 to 58
    • Study completion date: Oct 6, 2025 to Dec 2, 2026
Show 30 earlier versionsHide 30 earlier versions
  1. Study sites: 60 to 59v31
  2. Study sites: 58 to 60v30
  3. Study sites: 55 to 58v29
  4. Study sites: 53 to 55
    • Study completion date: Jul 8, 2026 to Oct 6, 2025
    v28
  5. Study sites: 52 to 53v27
  6. Study sites revised (52)v26
  7. Study sites: 51 to 52v25
  8. Study sites: 48 to 51v24
  9. Study sites: 46 to 48
    • Study description expanded, about 16 words
    • Eligibility criteria expanded, about 3 words
    • Study title expanded, about 3 words
    v23
  10. Lead sponsor: Genzyme, a Sanofi Company to Sanofi
    • Study sites: 38 to 46
    v22
  11. 2 versions Re-verified since Aug 17, 2023, no change to tracked fieldsv20-v21
  12. Study sites: 37 to 38v19
  13. Study sites: 38 to 37v18
  14. Study completion date: Jan 6, 2026 to Jul 8, 2026v17
  15. Study sites: 37 to 38v16
  16. Study sites: 33 to 37v15
  17. Eligibility criteria shortened, about 18 wordsv14
  18. Study sites: 30 to 33v13
  19. Study sites: 25 to 30v12
  20. Primary completion date: Nov 21, 2024 to Nov 30, 2024
    • Study completion date: Jan 5, 2026 to Jan 6, 2026
    v11
  21. Eligibility criteria expanded, about 48 words
    • Secondary endpoints: 11 to 12
    v10
  22. Study sites: 13 to 25v9
  23. Study sites: 3 to 13v8
  24. Study sites: 1 to 3v7
  25. Re-verified, no change to tracked fieldsv6
  26. Study completion date: Dec 26, 2025 to Jan 5, 2026
    • Site contact updated
    v5
  27. Study site revisedv4
  28. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 16, 2022 to Mar 11, 2022
    v3
  29. Primary endpoints revised (2)
    • Eligibility criteria shortened, about 34 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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).
Trial Details
NCT Number NCT05206773
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Fabry Disease
Related terms Fabry Disease
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov