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NCT05775848 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)
A Phase 3 study of Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I), sponsored by ML Bio Solutions.
- Active
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT05775848 is a Phase 3 study of Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I) that is active but no longer recruiting, run by ML Bio Solutions. The registered enrollment target is 81 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT05775848, a Phase 3 study of Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I), is active but no longer recruiting, sponsored by ML Bio Solutions.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2I/R9. The study will include patients ages 12 to 60, consistent with the existing preclinical toxicology profile. This will encompass the significant majority of existing diagnosed patients based upon the established epidemiology of the disease.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG BBP-418 (ribitol)
Study Locations (20)
Other
- Rigshospitalet, Neuromuscular Clinic and Research Unit - Copenhagen
- Charité Universitätsmedizin Berlin and Max Delbrück Center - Berlin
- IRCCS Ca' Granda Ospedale - Milan
- Leiden University Medical Center - Leiden
- Universitetssykehuset Nord-Norge, Department of Neurology - Tromsø
- Great Ormond Street Hospital for Children - London
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
- University of Pennsylvania - Philadelphia
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- University of California Irvine - Irvine
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Florida
- University of Florida - Gainsville
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05775848
The ClinicalTrials.gov registry entry for NCT05775848 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ML Bio Solutions, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05775848 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Pennsylvania, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05775848 about?
NCT05775848 is a clinical study titled "Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)". This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2I/R9. The study will include patients ages 12 to 60, consistent with the existing preclinical toxicology profile. This will encompass the significant majority of existing diagnosed patients ...
What is the current status of trial NCT05775848?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2023-05-31. Estimated completion is 2027-07.
What conditions does trial NCT05775848 study?
This clinical trial studies the following conditions: Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I).
What interventions are being tested in trial NCT05775848?
The interventions under investigation include: Placebo (OTHER), BBP-418 (ribitol) (DRUG).
Who is sponsoring clinical trial NCT05775848?
This trial is sponsored by ML Bio Solutions, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05775848 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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