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The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2

StatusRecruiting
PhasePhase 3
SponsorLupin Ltd.
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Mar 17, 2026 → Jun 2027
See other at-risk trials from Lupin Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 17, 2026 to Jun 2027 Show 5 more changesShow less
    • Study completion pushed from Apr 22, 2026 to Jun 2027
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 3 of 19 entries
    • Site details revised at 1 of 7 sites
    • Study description expanded, about 3 words
  2. Study sites: 6 to 7v4
  3. Primary endpoints: 2 to 1
    • Secondary endpoints: 18 to 19
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 27, 2024 to Feb 13, 2025
    • Study sites: 0 to 6
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Lupin Ltd.
8 trials monitored
See 1 trial at risk
A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 (HERCULES study) Study website: https://myotonicdystrophystudy.com/
Trial Details
NCT Number NCT06523400
Lead Sponsor Lupin Ltd.
Collaborators: Lupin Atlantis Holdings S.A.
Conditions
(from sponsor)		 Myotonic Dystrophy
Related terms Myotonic Dystrophy
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov