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Neurological & Neuromuscular

Myotonic Dystrophy (MD) Clinical Trials and Treatments

Also called MD, Dystrophia Myotonica, Steinert Disease

Myotonic Dystrophy is caused by a trinucleotide repeat expansion in the DMPK gene (DM1) or CNBP gene (DM2). In DM1, a CTG repeat expands in the 3' untranslated region, while DM2 involves CCTG repeats.

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About Myotonic Dystrophy

Myotonic Dystrophy is caused by a trinucleotide repeat expansion in the DMPK gene (DM1) or CNBP gene (DM2). In DM1, a CTG repeat expands in the 3' untranslated region, while DM2 involves CCTG repeats. The pathophysiology involves toxic accumulation of mutant mRNA, which sequesters RNA-binding proteins and disrupts normal RNA splicing and protein production. This leads to dysfunction of multiple proteins, including myosin, chloride channels, and sarcoplasmic reticulum calcium release channels, resulting in muscle damage and myotonia. The trinucleotide repeat number correlates with disease severity and age of onset, with longer repeats generally causing more severe disease with earlier presentation.

DM1 shows two main phenotypes: classic form with adult onset and congenital form with severe neonatal presentation and intellectual disability. DM2 generally has milder symptoms than DM1. Beyond skeletal muscle, MD affects smooth muscle, cardiac muscle, and the brain. Cardiac involvement ranges from conduction abnormalities to arrhythmias and dilated cardiomyopathy. Cerebral manifestations include intellectual disability in congenital forms, behavioral changes, cognitive decline, and increased risk of central sleep apnea. Cataracts are common, developing in teenagers with DM1. Endocrine dysfunction includes testicular atrophy, insulin resistance, and thyroid abnormalities.

Common Symptoms of Myotonic Dystrophy

Recognizing the signs of Myotonic Dystrophy early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Progressive muscle weakness and wasting
  • Myotonia causing stiff muscles that relax slowly after use
  • Facial drooping and weakness affecting chewing and swallowing
  • Ptosis and cataracts affecting vision
  • Cognitive and behavioral changes
  • Cardiac arrhythmias and conduction abnormalities

Who Myotonic Dystrophy Affects

Myotonic Dystrophy Type 1 (DM1) typically appears in adolescence to adulthood, though congenital forms occur in infants. Myotonic Dystrophy Type 2 (DM2) typically appears in adulthood. Affects males and females equally. Autosomal dominant inheritance with anticipation—children often have more severe disease and earlier onset. Occurs across all populations.

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Help Paying for Myotonic Dystrophy Treatment

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  • From a charity · Muscular Dystrophy Association
    MDA Durable Medical Equipment (DME) Grant Program fund
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    Pays for: Medical equipment (wheelchairs, lifts, canes and other DME), up to $1,000 per year.

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Status as each foundation showed it on September 28, 2026.

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Trusted Myotonic Dystrophy Resources

Reputable organizations and medical references for learning more about Myotonic Dystrophy, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Myotonic Dystrophy

Use this Myotonic Dystrophy clinical trial finder to see the 29 studies recruiting patients and 1 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for neurological & neuromuscular conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

44 active trials worldwide
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RECRUITINGPHASE3Recently updatedNCT07587242

A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping

Intervention: AOC 1044, Placebo

Sponsor: Avidity Biosciences, Inc.

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping

Ages 7 Years – 16 Years17 locations
Started Sep 2026Updated todayEst. May 2029 (~2y 8m)
RECRUITINGPHASE3Recently updatedNCT07486934

Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

Intervention: zeleciment basivarsen (DYNE-101), Placebo

Sponsor: Dyne Therapeutics

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment basivarsen (DYNE-101) for the treatment of myotonic dystrophy 1 (DM1).

Ages 16 Years+39 locations
Started May 2026Updated 4 days agoEst. Jul 2028 (~1y 10m)
RECRUITINGPHASE3Recently updatedNCT06523400

The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2

Intervention: Mexiletine granules for prolonged-release oral suspension, Placebo

Sponsor: Lupin Ltd. · Lupin Atlantis Holdings S.A.

A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 (HERCULES study)

Ages 16 Years+7 locations
Started Feb 2025Updated 5 days agoEst. Jun 2027 (~9 months)
RECRUITINGPHASE1, PHASE2Recently updatedNCT06844214

A Study to Investigate the Safety, Tolerability, and Efficacy of SAR446268, an Adeno-associated Viral Vector-mediated Gene Therapy in Participants Aged 10 to 55 Years of Age With Non-congenital Myotonic Dystrophy Type 1

Intervention: SAR446268

Sponsor: Sanofi

This is a Phase 1/Phase 2 open-label single arm, multicenter, and multinational study with SAR446268 for treatment of male and female participants 10 to 55 years old with non-congenital myotonic dystrophy (DM) type 1 (DM1).

Ages 10 Years – 55 Years10 locations
Started Jul 2025Updated 1 week agoEst. Feb 2029 (~2y 5m)
RECRUITINGRecently updatedNCT07700225

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) Extension

Sponsor: Virginia Commonwealth University · Dyne Therapeutics + 1 more

Myotonic Dystrophy type 1 (DM1) is an autosomal dominant multisystemic disorder that causes progressive disability and shortened life expectancy. It is characterized by progressive weakness and myotonia, which preferentially affects the craniofacial, hand, and distal leg muscles....

Ages 18 Years – 70 Years1 location
Started Sep 2026Updated 3 weeks agoEst. Dec 2032 (~6y 3m)
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Active trial locations30 cities in the US
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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Related Neurological & Neuromuscular Conditions

Other rare diseases in the neurological & neuromuscular category. Patients with Myotonic Dystrophy may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Companies Developing Myotonic Dystrophy Treatments

7 pharmaceutical companies have Myotonic Dystrophy in their rare disease portfolio

Frequently Asked Questions About Myotonic Dystrophy