Study Evaluating MYO-029 in Adult Muscular Dystrophy

Phase 1

Completed

• Conditions: Becker Muscular Dystrophy; Facioscapulohumeral Muscular Dystrophy; Limb-Girdle Muscular Dystrophy

• Registration Number: NCT00104078
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-02-22
• Study First Submitted QC: 2005-02-22
• Study First Posted: 2005-02-23
• Study Completion: 2007-01
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Written informed consent.
• Confirmed clinical and molecular diagnosis of Becker Muscular Dystrophy (BMD), Facioscapulohumeral Muscular Dystrophy (FSHD), or Limb-Girdle Muscular Dystrophy (LGMD)
• Independently ambulatory

Exclusion Criteria

• Patients with certain clinical conditions
• Patients using steroids or other medications with the potential to affect muscle function
• History of sensitivity to monoclonal antibodies or protein pharmaceuticals
• Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Safety assessment