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Study Evaluating MYO-029 in Adult Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00104078
Recruitment Status : Completed
First Posted : February 23, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2005
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety assessment

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104078


Locations
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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
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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ClinicalTrials.gov Identifier: NCT00104078    
Other Study ID Numbers: 3147K2-101
First Posted: February 23, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Dystrophies, Limb-Girdle
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked