Clinical trials

3

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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

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)

Participants needed: 176
Trial details
Phase: Phase 3Age: 16+Biological sex: AllType: InterventionalSponsor: Lupin Ltd.Updated: Feb 6, 2026Locations: 7
Eligibility criteria

DM1 or DM2 diagnosis confirmed genetically; [+10]

Are pregnant or lactating; [+26]

Status: Recruiting

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

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)

Participants needed: 24
Trial details
Phase: Phase 3Age: 16+Biological sex: AllType: InterventionalSponsor: Lupin Ltd.Updated: Dec 22, 2025Locations: 1
Eligibility criteria

Ability to comprehend and willingness to sign an informed consent (ICF) or ICF o... [+7]

Are pregnant or lactating; [+15]

Status: Recruiting

Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders

This is a prospective, open-label, multi-centre, single arm, registry study to collect standard relevant clinical and epidemiological data during routine medical evaluation and treatment in paediatric patients with myotonic disorders who are being treated with mexiletine therapy according to the physician.

Participants needed: 10
Trial details
Age: Up to 6Biological sex: AllType: ObservationalSponsor: Lupin Ltd.Updated: Sep 23, 2025Locations: 1Duration: 2 Years
Eligibility criteria

Male or female patients from birth to less than 6 years [+7]

Any contraindication to mexiletine as listed in the Namuscla Summary of Product... [+17]