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Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

Primary Purpose

Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis, Spinobulbar Muscular Atrophy

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

leuprolide

testosterone

About this trial

This is an interventional treatment trial for Spinal Muscular Atrophy focused on measuring amyotrophic lateral sclerosis, motor neuron disease, neurologic and psychiatric disorders, rare disease, spinal and bulbar muscular atrophy, spinal muscular atrophy, Kennedy's Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Men aged 18 and over with motor neuron disease, i.e.: X-linked spinal and bulbar muscular atrophy (Kennedy's disease) Confirmed by androgen receptor, exon-1 mutation genotype Amyotrophic lateral sclerosis Spinal muscular atrophy Significant muscle weakness on manual muscle testing No prisoners No mental disability

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004771

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT00004771

Brief Title

Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2001

Overall Recruitment Status

Completed

Study Start Date

October 1992 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Ohio State University

4. Oversight

5. Study Description

Brief Summary

OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.

Detailed Description

PROTOCOL OUTLINE: All patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis, Spinobulbar Muscular Atrophy

Keywords

amyotrophic lateral sclerosis, motor neuron disease, neurologic and psychiatric disorders, rare disease, spinal and bulbar muscular atrophy, spinal muscular atrophy, Kennedy's Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

leuprolide

Intervention Type

Drug

Intervention Name(s)

testosterone

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerry R. Mendell

Organizational Affiliation

Ohio State University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

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