Back to resultsStudy Evaluating MYO-029 in Adult Muscular Dystrophy
Primary Purpose
Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MYO-029
Sponsored by
About this trial
This is an interventional treatment trial for Becker Muscular Dystrophy
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00104078
First Posted
February 22, 2005
Last Updated
December 19, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00104078
Brief Title
Study Evaluating MYO-029 in Adult Muscular Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MYO-029
Primary Outcome Measure Information:
Title
Safety assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-7519
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating MYO-029 in Adult Muscular Dystrophy
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