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NCT03692312 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy

A Phase 2 study, sponsored by AMO Pharma Limited.

Completed
Registry status
Phase 2
Development phase
56
Enrollment target

NCT03692312: Completed Phase 2 study, sponsored by AMO Pharma Limited.

NCT03692312 is a Phase 2 study that has completed, run by AMO Pharma Limited. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03692312, a Phase 2 study, has completed, sponsored by AMO Pharma Limited.

COMPLETED
Registry status
Phase 2
Development phase
56 participants
Enrollment target

Study 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).

Primary Outcome

The Clinician-Completed Congenital DM1 Scale is an 11-item rating scale completed by the clinician that scores the symptom severity of domains that are clinically relevant in Congenital DM1. The severity of the clinician's concern in each domain is scored by using a 5-point Likert Scale. Scores range from 0 = Not present to 4 = Very severe.

Interventions

  • DRUG Placebo
  • DRUG Tideglusib

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2021-03-03
Est. Completion 2023-04-04
Phase Phase 2
AMO Pharma Limited

2 total trials

What the finished NCT03692312 record still lists

NCT03692312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03692312 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03692312 about?

NCT03692312 is a clinical study titled "Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy". 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).

What is the current status of trial NCT03692312?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2021-03-03. Estimated completion is 2023-04-04.

What interventions are being tested in trial NCT03692312?

The interventions under investigation include: Placebo (DRUG), Tideglusib (DRUG).

Who is sponsoring clinical trial NCT03692312?

This trial is sponsored by AMO Pharma Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03692312's enrollment target sits among peer trials

56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03692312, the US trial registry maintained by the National Library of Medicine. NCT03692312 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.