An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of BBP-418 (Ribitol) in Participants with Limb-Girdle Muscular Dystrophy 2I/R9 (LGMD2I/R9)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524371-23-00

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limb Girdle Muscular Dystrophy (LGMD) Type 2I

Brief summary

-Frequency and severity of TEAEs and treatment-emergent SAEs - Change from baseline in NSAD at EOT

Detailed description

• Change from baseline in the following endpoints at EOT: o 10MWT (m/s) o FVC (percent predicted, performed in a sitting position) o PUL 2.0 (for participants who are non-ambulatory at OLE baseline) o 100MTT • Change from baseline in serum CK at EOT

Interventions

DRUGRibitol

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
-Frequency and severity of TEAEs and treatment-emergent SAEs - Change from baseline in NSAD at EOT	—

Secondary

Measure	Time frame
• Change from baseline in the following endpoints at EOT: o 10MWT (m/s) o FVC (percent predicted, performed in a sitting position) o PUL 2.0 (for participants who are non-ambulatory at OLE baseline) o 100MTT • Change from baseline in serum CK at EOT	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 17, 2026