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Completed
NCT05479981
Extension of AOC 1001-CS1 (MARINA) Study in Adult Myotonic Dystrophy Type 1 (DM1) Patients
Conditions: DM1, Muscular Dystrophies, Myotonic Dystrophy, Myotonic Dystrophy 1, Myotonic Disorders, Muscular Disorders, Atrophic, Muscular Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Nervous System Diseases, Genetic Diseases, Inborn, Heredodegenerative Disorders, Nervous System, Neurodegenerative Diseases
Sex: All
Ages: 18 Years – 66 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 37
Sponsor: Avidity Biosciences, Inc.
Location: University of California Los Angeles Los Angeles California
Summary
AOC 1001-CS2 (MARINA-OLE) (NCT05479981) is a Phase 2 extension of the AOC 1001-CS1 (MARINA) (NCT05027269) study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple-doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients
Eligibility Criteria
Key Inclusion Criteria:
* Completion of AOC 1001-CS1 (MARINA) study with satisfactory compliance and no significant tolerability issues
Key Exclusion Criteria:
* Pregnancy, intent to become pregnant, or active breastfeeding
* Unwilling or unable to continue to comply with contraceptive requirements
* Any new conditions or worsening of existing conditions that in the opinion of the investigator or sponsor would make the participant unsuitable for the study or could interfere with participation or completion of the study
Source: ClinicalTrials.gov (NCT05479981). StuddyBuddy aggregates publicly available trial information.
