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An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

StatusRecruiting
PhasePhase 3
SponsorLupin Ltd.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jul 8, 2026 to Jan 22, 2027
    • Study completion date: Oct 4, 2026 to Feb 22, 2027
    • Start date changed from estimate of Oct 1, 2025 to Sep 3, 2025
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Sep 3, 2025 to Oct 1, 2025
    v4
  3. Notable Start date: Jul 30, 2025 to Sep 3, 2025v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
8 trials monitored
See 1 trial at risk
An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR compared to Mexiletine IR in Patients with Non-Dystrophic Myotonias (ACHILLES study)
Trial Details
NCT Number NCT07097701
Lead Sponsor Lupin Ltd.
Collaborators: Lupin Atlantis Holdings S.A.
Conditions
(from sponsor)
Myotonia
Related terms Myotonia
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov