Open Actively Recruiting

Extension of AOC 1001-CS1 (MARINA) Study in Adult Myotonic Dystrophy Type 1 (DM1) Patients

About

Brief Summary

AOC 1001-CS2 (MARINA-OLE) is a Phase 2 extension of the AOC 1001-CS1 (MARINA) 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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
66 Years

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

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Study Stats
Protocol No.
22-5021
Category
Neurology
Contact
Emilie Douine
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05479981
For detailed technical eligibility, visit ClinicalTrials.gov.