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An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study.

StatusEnrolling by Invitation
PhasePhase 3
SponsorLupin Ltd.
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: 2 to 1
    • Secondary endpoints: 26 to 27
    v4
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 6
    • Start date changed from estimate of Aug 18, 2025 to Sep 12, 2025
    v3
  3. Primary completion date: Apr 17, 2027 to May 29, 2028
    • Start date: Feb 27, 2025 to Aug 18, 2025
    • Study completion date: Jun 22, 2027 to Jul 6, 2028
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is an open-label extension study intended to evaluate the long-term safety and efficacy of mexiletine PR in patients with myotonic dystrophy type 1 and type 2 (DM1 and DM2) who have completed the parent study MEX-DM-302.
Trial Details
NCT Number NCT06549400
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