Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1 (NCT07486934)
A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: UCSD - Altman Clinical and Translational Research Institute — La Jolla, California
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (34 Sites)
Showing the first 25 of 34 sites.
- UCSD - Altman Clinical and Translational Research Institute — La Jolla, California
- UCLA Medical Center (Department of Neurology) — Los Angeles, California
- Rare Disease Research, LLC — Atlanta, Georgia
- IU Health Neuroscience Center — Indianapolis, Indiana
- Roy Blunt NextGen Precision Health Institute — Columbia, Missouri
- Rare Disease Research, LLC — Hillsborough, North Carolina
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas
- University of Utah Clinical Neurosciences Center — Salt Lake City, Utah
- Virginia Commonwealth University - Biotech One — Richmond, Virginia
- UZA — Edegem,
- UZ Leuven — Leuven,
- Rigshospitalet, (Neuromuscular Clinic and Research Unit, Department 8077) — Copenhagen,
- AP-HP, Hôpital Raymond-Poincaré — Garches,
- CHU Marseille - Hôpital de la Timone (APHM) — Marseille,
- CHU de Nantes - Hôtel-Dieu — Nantes,
- Pitié-Salpêtrière Hospital — Paris,
- CHU de Toulouse - Hôpital Pierre-Paul Riquet — Toulouse,
- LMU Klinikum der Universität München Neurologische Klinik und Poliklinik Friedrich-Baur-Institut Campus Innenstadt — Munich, Bavaria
- Universitätsklinikum Bonn AöR Zentrum für Neurologie Klinik für Neuroimmunologie und Neuromuskuläre Erkrankungen — Bonn, North Rhine-Westphalia
- Charité Universitätsmedizin Berlin Campus-Buch Muscle Research Unit — Berlin, State of Berlin
- Centro Clinico Nemo Brescia, Fondazione Serena ETS — Gussago, Brescia
- Centro Clinico Nemo Milano, Fondazione Serena ETS — Milan, Milano
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Department of Women's, Child and Public Health Sciences - UOC Neuropsichiatria Infantile — Roma, Roma
- Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neurologia — Roma, Roma
- Niigata National Hospital, National Hospital Organization — Kashiwazaki, Niigata
📞 Contact the Study Coordinator
Phone: (781) 317-1919
Email: clinicaltrials@dyne-tx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Myotonic Dystrophy Type 1 (DM1)
- A Remote Physical Activity Program in the Population Suffering from Type 1 Myotonic Dystrophy — Jonquière, Quebec
- A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) — San Carlos, California
- Remote Assessments and Genetic Determinants of Myotonic Dystrophy — Rochester, New York
- Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1 — Stanford, California
Explore by condition: All Myotonic Dystrophy Type 1 (DM1) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.