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Long-Term Effects of BBP-418 (Ribitol) in Participants with LGMD2I/R9
EU CTIS ID: 2025-524371-23-00
What this study is testing
To assess the long-term safety of BBP-418 in participants with LGMD2I/R9 To assess the long-term clinical efficacy of BBP-418 in participants with LGMD2I/R9
- 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. Completed Study MLB-01-005 on study drug through the final clinic visit (Month 36 or another qualifying end-of-study visit as determined by the Sponsor). 2. The participant (or parent/guardian) who signs the ICF understands the study procedures and agrees to participate in the study by giving informed consent (or assent, if <18 years of age). 3. Is willing and able to complete all study procedures according to the Schedule of Assessments. 4. A WOCBP or a nonsterile male participant must be willing to use an acceptable method of contraception (see Section 5.3) from the time of consent through 30 days after the last dose of study drug in this study.
You likely can't join if
- 1. Has developed clinically significant concomitant disease that would, in the Investigator’s opinion, be likely to unfavorably impact study participation, including: a. Any significant concomitant medical condition, including psychiatric, cardiac, renal, pulmonary, hepatic, or endocrine disease other than that associated with LGMD2I/R9. b. Any other significant laboratory, vital sign, ECG abnormality, clinical history, or finding. 2. Is pregnant (based on the Baseline / Day 1 pregnancy test result) and/or breastfeeding or planning to conceive children within the projected duration of the study through 30 days after the last dose of study drug in this study. 3. Has active suicidal ideation, defined as having a suicide ideation score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS at Baseline / Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; 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.