Study Evaluating MYO-029 in Adult Muscular Dystrophy

NCT ID: NCT00104078

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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Conditions

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Becker Muscular Dystrophy Facioscapulohumeral Muscular Dystrophy Limb-Girdle Muscular Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MYO-029

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Washington D.C., District of Columbia, United States

Site Status

Kansas City, Kansas, United States

Site Status

Baltimore, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

St Louis, Missouri, United States

Site Status

Rochester, New York, United States

Site Status

Columbus, Ohio, United States

Site Status

Dallas, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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3147K2-101

Identifier Type: -

Identifier Source: org_study_id