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Phase 1/2 study of mRNA-3705 in participants with Isolated MMA (Extension Study).
EU CTIS ID: 2022-501997-20-00
What this study is testing
Evaluate the long-term safety of mRNA-3705 administered to participants with MMA who have previously participated in other clinical studies of mRNA-3705
- Phase I and Phase II (Integrated)- First administration to humans
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. Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive does of study drug due to COVID-19 vaccination during Study mRNA-3705-P101 Part 1
- 2. Completed the EOT Visit (or EOS Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension study.
- 3. Participant’s caregiver (and, if able to provide consent/assent, the participant) is willing and able to comply with study-related assessments.
- 4. Participant and/or legally authorized representative is willing and able to provide informed consent and/or assent as mandated by local regulations.
You likely can't join if
- Not expected to receive clinical benefit from continued mRNA-3705 administration, in the opinion of the Investigator.
- Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
- History of liver and/or kidney transplant.
- Pregnant or breastfeeding.
- Sexually active and does not agree to use a highly effective method of contraception (Section 10.4) from enrollment and through 3 months after the last dose of the study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
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. 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.