Study Evaluating MYO-029 in Adult Muscular Dystrophy

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00104078

First received: February 22, 2005

Last updated: December 19, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2005

Last Updated Date

December 19, 2007

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Becker Muscular Dystrophy
Facioscapulohumeral Muscular Dystrophy
Limb-Girdle Muscular Dystrophy

Intervention ^ICMJE

Drug: MYO-029

Study Arm (s)

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

108

Completion Date

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00104078

Other Study ID Numbers ^ICMJE

3147K2-101

Has Data Monitoring Committee

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

Information Provided By

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

To Top