Muscular Dystrophy Trial, Recruiting NCT03981575 Sponsor: Virginia Commonwealth University Condition: Muscular Dystrophy
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Muscular Dystrophy Trial, Recruiting

NCT03981575
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 70 years old (inclusive)
  • You are able to understand and agree to participate in the study on your own
  • You have been diagnosed with Myotonic Dystrophy Type 1 (DM1) either through a clinical diagnosis (based on muscle stiffness, muscle weakness in certain areas, and a family history of similar symptoms) or through a confirmed genetic test

Who may not be able to join:

  • You have serious kidney or liver disease, poorly controlled diabetes, an uncontrolled thyroid condition, or an active cancer (other than skin cancer)
  • You currently have a problem with alcohol or drug misuse
  • You are currently enrolled in another clinical trial for DM1, or have taken part in one within the last 6 months
  • You are currently pregnant or planning to become pregnant during the study
  • You have another medical condition that, in the opinion of the study team, would affect your ability to complete the study tasks

For the optional muscle biopsy part of the study only — additional people who may not be able to join:

  • Your genetic test shows fewer than 100 CTG repeats, unless you have clear signs of limb weakness and muscle loss (confirm with trial site)
  • You take blood-thinning medications such as warfarin or dabigatran
  • Your platelet count (a measure of blood clotting cells) is below 50,000, if this is known
  • You have a history of a bleeding disorder
  • The muscle targeted for biopsy (in your lower leg) has wasted away too much to provide a usable sample
  • You have previously had a muscle biopsy taken from either lower leg

Note: People who are unable to walk are not automatically excluded from the main trial, but their numbers are limited to less than 15% of total participants.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Nicholas Johnson, MD, Virginia Commonwealth University

Phone: 804-828-6318

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 January 2019
Est. completion
1 October 2026

Where this trial is recruiting

🇨🇦 Canada 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change in ambulation over 24 months as measured by the 10 meter walk (m/s).; Change in respiratory function over 24 months as measured by spirometry, specifically the supine forced vital capacity (FVC).; Percent splicing of DM1-affected splice events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov