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BBP-418 for Limb-Girdle Muscular Dystrophy
Study Summary
This trial will test the safety and tolerability of a new drug, BBP-418, for people with a certain kind of muscle dystrophy. There is currently no approved treatment for this condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a serious health condition alongside my cancer.I have a genetic diagnosis of LGMD2I and show signs of muscle weakness.I have not been on any experimental treatments or devices for the last 60 days.I am not on prescription medication for conditions other than LGMD2I, except for mild issues approved by the study leader.I have a gut condition or surgery that could affect how I absorb pills.I can walk 10 meters in 12 seconds or less, or I cannot walk this distance unaided.I do not have major health issues unrelated to LGMD2I.I weigh more than 30 kilograms.You haven't taken any supplements containing ribose or other sugar alcohols within 60 days before the start of the trial.I have not used corticosteroids in the last 60 days.I have a condition that prevents safe muscle biopsy.You have a history of drug abuse, including alcohol addiction, within the past 2 years before agreeing to participate.
- Group 1: Cohort 2
- Group 2: Cohort 1
- Group 3: Cohort 3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment allow senior citizens to participate?
"Applicants accepted into this medical trial must be between 12 and 55 years of age."
Are there any unfilled spots available in this clinical trial?
"Per the details published on clinicaltrials.gov, this medical experiment is not currently enrolling candidates. This particular investigation was first posted online in February 2021 and most recently updated in December of last year; however, there are two distinct studies that remain open for recruitment at present."
Am I eligible to participate in this clinical research?
"This clinical trial is recruiting 14 individuals aged 12-55 years, who have lgmd2i (fkrp) and meet the following criteria: Able to complete a 10-meter walk test in ≤12 seconds without assistance ("moderate disease") or are with "severe disease"/non-ambulatory as indicated by an inability to accomplish a 10-meter walk unaided in >12 seconds; Have body weight exceeding 30 kg, Willingness to utilize an appropriate contraceptive method from the time of consent through 12 weeks after they receive their last dose."
Has the FDA sanctioned BBP-418 for medical use?
"Our experts at Power appraised the safety of BBP-418 on a scale from 1 to 3, and gave it an intermediate score of 2. This is because there are some available data points demonstrating its security but none indicating efficacy."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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