Study Evaluating MYO-029 in Adult Muscular Dystrophy

Becker Muscular Dystrophy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104078
• Other study ID #: 3147K2-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 22, 2005
• Last updated: December 19, 2007
• Start date: February 2005
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Becker Muscular Dystrophy
• Facioscapulohumeral Muscular Dystrophy
• Limb-Girdle Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Muscular Dystrophy, Facioscapulohumeral

Intervention

Drug:
• MYO-029

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment