Study Evaluating MYO-029 in Adult Muscular Dystrophy

This study has been completed.

First Received: February 22, 2005 Last Updated: December 19, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00104078

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 I Phase II

Genetics Home Reference related topics: Duchenne and Becker muscular dystrophy facioscapulohumeral muscular dystrophy L1 syndrome

MedlinePlus related topics: Muscular Dystrophy

Drug Information available for: Stamulumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Further study details as provided by Wyeth:

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

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

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

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

Study placed in the following topic categories:

Becker's Muscular Dystrophy
Facioscapulohumeral Muscular Dystrophy 1a
Limb-girdle Muscular Dystrophy
Muscular Dystrophy, Facioscapulohumeral
Muscular Dystrophy, Duchenne and Becker Type
Muscular Dystrophies
Muscular Dystrophies, Limb-Girdle
Muscular Diseases
Muscular Disorders, Atrophic

Musculoskeletal Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Muscular Dystrophy, Duchenne
Duchenne Muscular Dystrophy
Genetic Diseases, X-Linked
Atrophy
Landouzy-Dejerine Muscular Dystrophy
Muscular Dystrophy

Additional relevant MeSH terms:

Muscular Dystrophy, Facioscapulohumeral
Muscular Dystrophies
Muscular Diseases
Muscular Dystrophies, Limb-Girdle
Genetic Diseases, Inborn
Neuromuscular Diseases

Musculoskeletal Diseases
Muscular Disorders, Atrophic
Muscular Dystrophy, Duchenne
Nervous System Diseases
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 07, 2009