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Trial record 1 of 1 for:    NCT00104078
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Study Evaluating MYO-029 in Adult Muscular Dystrophy

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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

Tracking Information
First Submitted Date  ICMJE February 22, 2005
First Posted Date  ICMJE February 23, 2005
Last Update Posted Date December 28, 2007
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
Safety assessment
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00104078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating MYO-029 in Adult Muscular Dystrophy
Official Title  ICMJE Not Provided
Brief Summary The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Becker Muscular Dystrophy
  • Facioscapulohumeral Muscular Dystrophy
  • Limb-Girdle Muscular Dystrophy
Intervention  ICMJE Drug: MYO-029
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 21, 2005)
108
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00104078
Other Study ID Numbers  ICMJE 3147K2-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP