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An Open-label, Non-Comparative Study to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of Mexiletine in Adolescents and Children With Myotonic Disorders

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Trial Profile

An Open-label, Non-Comparative Study to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of Mexiletine in Adolescents and Children With Myotonic Disorders

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 May 2024

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At a glance

  • Drugs Mexiletine (Primary)
  • Indications Myotonic dystrophy; Nondystrophic myotonia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Lupin

    • Most Recent Events

    • 03 May 2024 Planned End Date changed from 12 Mar 2024 to 8 Aug 2024.
    • 03 May 2024 Planned primary completion date changed from 12 Mar 2024 to 24 Jun 2024.
    • 04 Oct 2023 Planned primary completion date changed from 27 Jan 2024 to 12 Mar 2024.

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