Study Evaluating MYO-029 in Adult Muscular Dystrophy

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00104078
First received: February 22, 2005
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Becker Muscular Dystrophy
Facioscapulohumeral Muscular Dystrophy
Limb-Girdle Muscular Dystrophy
Drug: MYO-029
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety assessment

Estimated Enrollment: 108
Study Start Date: February 2005
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104078

Locations
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Kansas
Kansas City, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States, 21287-7519
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Rochester, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Texas
Dallas, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104078     History of Changes
Other Study ID Numbers: 3147K2-101
Study First Received: February 22, 2005
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscular Dystrophy, Facioscapulohumeral
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Dystrophies, Limb-Girdle
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on September 22, 2014