Study Evaluating MYO-029 in Adult Muscular Dystrophy

Wyeth

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: MYO-029

Study type: Interventional

Funder types: Industry

Identifiers

NCT00104078

3147K2-101

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind