NCT00104078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

February 22, 2005

Last Update Submit

December 19, 2007

Conditions

Becker Muscular DystrophyFacioscapulohumeral Muscular DystrophyLimb-Girdle Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Safety assessment

Interventions

MYO-029DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Baltimore, Maryland, 21287-7519, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular Dystrophy, FacioscapulohumeralMuscular Dystrophies, Limb-Girdle

Interventions

Stamulumab

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2005

First Posted

February 23, 2005

Study Start

February 1, 2005

Study Completion

January 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

US(9)