- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104078
Study Evaluating MYO-029 in Adult Muscular Dystrophy
December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
108
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
-
-
Kansas
-
Kansas City, Kansas, United States
-
-
Maryland
-
Baltimore, Maryland, United States, 21287-7519
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Missouri
-
St. Louis, Missouri, United States
-
-
New York
-
Rochester, New York, United States
-
-
Ohio
-
Columbus, Ohio, United States
-
-
Texas
-
Dallas, Texas, United States
-
-
Utah
-
Salt Lake City, Utah, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
February 22, 2005
First Submitted That Met QC Criteria
February 22, 2005
First Posted (Estimate)
February 23, 2005
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3147K2-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Becker Muscular Dystrophy
-
Virginia Commonwealth UniversityEdgewise Therapeutics, Inc.RecruitingMuscular Dystrophies | Becker Muscular Dystrophy | Muscular Dystrophy in Children | Muscular Dystrophy, BeckerUnited States, United Kingdom
-
Boston Children's HospitalNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingLimb-girdle Muscular Dystrophy | Neuromuscular; Disorder, Hereditary | Duchenne/Becker Muscular DystrophyUnited States
-
University Children's Hospital, ZurichUnknownDuchenne / Becker Muscular DystrophySwitzerland
-
Gaziosmanpasa Research and Education HospitalCompletedDuchenne or Becker Muscular DystrophyTurkey
-
ItalfarmacoCompletedDuchenne and Becker Muscular Dystrophy | Polycytemia VeraCanada
-
InCor Heart InstituteUniversity of Sao Paulo; Federal University of Minas GeraisCompletedMyocardial Fibrosis | Muscular Dystrophies
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedMuscular Dystrophies | Duchenne Muscular Dystrophy | Becker Muscular Dystrophy | Limb-Girdle Muscular DystrophyUnited States
-
RSPR Pharma ABCompletedDuchenne Muscular Dystrophy | Becker Muscular DystrophySweden
-
National Institute of Neurological Disorders and...CompletedDuchenne Muscular Dystrophy | Becker Muscular DystrophyUnited States
-
CureDuchenneRecruitingDuchenne Muscular Dystrophy | Becker Muscular DystrophyUnited States
Clinical Trials on MYO-029
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeCompletedHead and Neck CancerUnited States
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeCompleted
-
Nantes University HospitalCompletedMultiple SclerosisFrance
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeCompletedPrimary Soft-tissue SarcomaUnited States
-
Liberating Technologies, Inc.Completed
-
Kessler FoundationUnited States Department of DefenseCompleted
-
Postgraduate Institute of Dental Sciences RohtakUnknownPolycystic Ovary Syndrome | Periodontitis | Insulin Resistance
-
Instituto Mexicano del Seguro SocialMassachusetts General Hospital; Fundacion Rio ArronteActive, not recruitingOverweight and Obesity | Gestational DiabetesMexico
-
Mansoura UniversityUnknown