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A Phase 3 Global Study to Evaluate AOC 1001 for the Treatment of Myotonic Dystrophy Type 1
EU CTIS ID: 2024-511378-60-00
What this study is testing
To evaluate the efficacy of AOC 1001 on hand function.
- 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. Age: 16 to 65. Age: 18-65 (Denmark, Germany)
- 2. Clinical and genetic diagnosis (CTG repeat length ≥ 100) of DM1.
- 3. Ability to walk independently (orthoses and ankle braces allowed) for at least 10 meters at screening.
You likely can't join if
- 1. Breastfeeding, pregnancy, or intent to become pregnant during the study.
- 2. Unwilling or unable to comply with contraceptive requirements.
- 3. Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study.
- 4. Diabetes that is not adequately controlled.
- 5. History of decompensated heart failure within 3 months of screening. Participants with preexisting pacemaker/ICD are not excluded.
- 6. Body Mass Index > 35 kg/m2 at Screening.
See the full eligibility criteria
- 1. Age: 16 to 65. Age: 18-65 (Denmark, Germany)
- 2. Clinical and genetic diagnosis (CTG repeat length ≥ 100) of DM1.
- 3. Ability to walk independently (orthoses and ankle braces allowed) for at least 10 meters at screening.
- 1. Breastfeeding, pregnancy, or intent to become pregnant during the study.
- 2. Unwilling or unable to comply with contraceptive requirements.
- 3. Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study.
- 4. Diabetes that is not adequately controlled.
- 5. History of decompensated heart failure within 3 months of screening. Participants with preexisting pacemaker/ICD are not excluded.
- 6. Body Mass Index > 35 kg/m2 at Screening.
- 7. Recently treated with an investigational drug or biological agent.
- 8. Treatment with anti-myotonic medication within 5 half-lives or 14 days of baseline, whichever is longer, prior to baseline.
- 9. Note: Additional protocol defined inclusion and exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Japan
- United Kingdom
- Canada
- Australia
- United States
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Japan; United Kingdom; Canada; Australia; United States. 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.