CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
Tideglusib +1 moredrug
Likely dose
Tideglusib 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03692312
NCT03692312Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Tideglusib Versus Placebo for the Treatment of Children and Adolescents With Congenital Myotonic Dystrophy (REACH CDM)

AMO Pharma Limited·interventional·Posted Oct 2, 2018·Updated Oct 8, 2025

In Brief

A Phase 3 clinical trial evaluating Tideglusib and Placebo for Congenital Myotonic Dystrophy. Completed, enrolled 56 participants across 14 sites in 5 countries.

Detailed Summary

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of patients (aged 6 to 16 years) diagnosed with Congenital Myotonic Dystrophy (Congenital DM1).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Myotonic Dystrophy
CountriesAustralia, Canada, New Zealand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2018
Enrollment StartMar 3, 2021
Primary CompletionApr 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.8 years ago

Interventions

Tideglusibdrug

Tideglusib for oral suspension, weight-adjusted at 400mg, 600mg or 1000 mg dose levels, once daily

Placebodrug

Matching placebo formulation