A Global Phase 3 Open-Label Extension Study to Assess AOC 1001 in Patients with DM1
EU CTIS ID: 2025-520766-22-00
What this study is testing
To evaluate the long-term safety and tolerability of AOC 1001 in DM1 patients
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Ability to provide written informed consent (signed and dated) and any authorizations required by local law and be willing and able to comply with all study requirements. When enrolling participants who are minors, it is necessary to also obtain consent from a legally authorized representative and the participant will receive information in a way adapted to their age and mental maturity.
- 2. Completion of any prior AOC 1001 studies with satisfactory completion of dosing and follow-up assessments and satisfactory compliance with the protocol requirements of the parent study, as determined by the Investigator.
You likely can't join if
- 1. Females who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- 2. Unwilling to comply with contraceptive requirements.
- 3. Any new conditions or worsening of existing condition that in the opinion of the Investigator would make the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.