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Active, not recruiting Phase 3 Interventional

Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

ClinicalTrials.gov ID: NCT05775848

Public ClinicalTrials.gov record NCT05775848. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05775848
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
ML Bio Solutions, Inc.
Industry
Enrollment
112 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2023 (Actual)
Primary completion
Sep 2027 (Estimated)
Completion
Sep 2027 (Estimated)
Last update posted
Sep 9, 2026

2023 – 2027

United States locations

U.S. sites
13
U.S. states
12
U.S. cities
12
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
University of California Irvine Irvine California 92697 —
University of Colorado Anschutz Medical Campus Aurora Colorado 80045 —
University of Florida Gainesville Florida 32610 —
University of Iowa Iowa City Iowa 52242 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Kennedy Krieger Institute Baltimore Maryland 21205 —
University of Minnesota, Twin Cities Minneapolis Minnesota 55455 —
Washington University School of Medicine St Louis Missouri 63110 —
Oregon Health & Science University (OHSU) - Neurology Clinic - South Waterfront Portland Oregon 97239 —
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Children's Hospital of the Kings Daughters Norfolk Virginia 23455 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05775848, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05775848 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →