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: Completed

Phase of Trial: Phase III

Latest Information Update: 08 Jul 2026

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At a glance

01 Jul 2026 According to a Lupin media release, the European Medicines Agency (EMA) approved a change to the terms of marketing authorization for NaMuscla, supported by the Pediatric Investigation Plan (PIP). The approval includes two new dosage strengths, 62 mg and 83 mg capsules, in addition to the existing 167 mg, and the revised indications that cover symptomatic treatment of myotonia in children, adolescents, and adults with non-dystrophic disorders.
25 Nov 2024 Status changed from recruiting to completed.
03 May 2024 Planned End Date changed from 12 Mar 2024 to 8 Aug 2024.

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