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Study Evaluating MYO-029 in Adult Muscular Dystrophy

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NCT00104078

Last updated on November 19, 2019
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FOR MORE INFORMATION
Study Location
Washington, District of Columbia, 20010 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00104078
Pfizer
Completed
Study Evaluating MYO-029 in Adult Muscular Dystrophy

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Descriptive Information
Brief Title  ICMJE Study Evaluating MYO-029 in Adult Muscular Dystrophy
Official Title  ICMJE Not Provided
Brief SummaryThe purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.
Detailed DescriptionNot 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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