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An Open-label Extension Study Evaluating the Long-term Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-670 in Adult Subjects with Myotonic Dystrophy Type I

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517983-47-00
Acronym
VX-24-670-101
Enrollment
14
Registered
2025-06-03
Start date
2025-12-09
Completion date
Unknown
Last updated
2025-07-25

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

Conditions

Myotonic Dystrophy

Brief summary

Safety and tolerability of VX-670 based on the assessment of adverse events (AEs), vital signs, electrocardiograms (ECGs), and clinical laboratory values

Detailed description

Change from baseline in splicing in tibialis anterior muscle biopsy at Week 24 VX-670 and PMO-0221a concentration in plasma and muscle tissues

Interventions

Sponsors

Vertex Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Safety and tolerability of VX-670 based on the assessment of adverse events (AEs), vital signs, electrocardiograms (ECGs), and clinical laboratory values

Secondary

MeasureTime frame
Change from baseline in splicing in tibialis anterior muscle biopsy at Week 24 VX-670 and PMO-0221a concentration in plasma and muscle tissues

Countries

Belgium, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026