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

NCT07097701 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-22

No results posted yet for this study

Summary

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)

Conditions

  • Myotonia

Interventions

DRUG

Granular powder in unit dose foil-lined sachet Mexiletine (PR)

Mexiletine (PR)

DRUG

Oral Capsule Mexiletine (IR)

Mexiletine (IR)

Sponsors & Collaborators

  • Lupin Atlantis Holdings S.A.

    collaborator UNKNOWN

  • Lupin Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2027-01-22
Completion
2027-02-22

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07097701 on ClinicalTrials.gov