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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00104078
Other study ID # 3147K2-101
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 22, 2005
Last updated December 19, 2007
Start date February 2005
Est. completion date January 2007

Study information

Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MYO-029


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety assessment
See also
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