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Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2

NCT04700046 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-05-06

No results posted yet for this study

Summary

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Mexiletine During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 \[The MIND Study\]

Conditions

  • Myotonic Dystrophy Type 1 and Type 2

Interventions

DRUG

Mexiletine 167 mg

Mexiletine 167 mg (equivalent to mexiletine HCl 200 mg) immediate release, oral capsules.

DRUG

Placebo

The placebo capsules contain the same ingredients as the active formulation with the exception of mexiletine

Sponsors & Collaborators

  • Lupin Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2024-07-01
Completion
2024-08-12

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Entities

Drugs

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 NCT04700046 on ClinicalTrials.gov