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Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 65 sites Publications: details revised at 1 of 1 entry · Eligibility criteria expanded, about 3 words Show 2 more changesShow less
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. 2 versions Re-verified since May 13, 2026, no change to tracked fieldsv20-v21
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Enrollment target: estimated 300 to confirmed 455v19 Show 1 more changeShow less
    • Enrollment target: estimated 300 to confirmed 455
  4. Re-verified, no change to tracked fieldsv18
  5. Study sites: 64 to 65v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites revised (64)v16 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 63 to 64v15
  3. Study sites: 61 to 63v14
  4. Study sites: 59 to 61v13
  5. Study sites: 57 to 59v12
  6. Study sites: 53 to 57v11
  7. Study sites: 49 to 53v10
  8. Study sites: 41 to 49v9
  9. Study sites: 37 to 41v8
  10. Study sites: 25 to 37v7
  11. Study sites: 21 to 25v6
  12. Study sites: 18 to 21v5
  13. Study sites: 3 to 18 Secondary endpoints: details revised at 1 of 2 entries · Study description shortened, about 22 wordsv4 Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description shortened, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  14. Primary and study completion dates: Jan 2027 to Jan 25, 2027 Start date changed from estimate of Dec 2024 to Dec 18, 2024 · Secondary endpoints: details revised at 1 of 2 entries · Study description expanded, about 22 words · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2024 to Dec 18, 2024
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 22 words
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  15. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 3v2 Show 1 more changeShow less
    • Study sites: 0 to 3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.
Trial Details
NCT Number NCT06696443
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Diabetic Peripheral Neuropathic Pain
Enrollment 455 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov