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

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-10-31

Brief Summary

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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

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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.

Conditions

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Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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leuprolide

Intervention Type DRUG

testosterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Jerry R. Mendell

Role: STUDY_CHAIR

Ohio State University

Other Identifiers

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OSU-92H0325

Identifier Type: -

Identifier Source: secondary_id

199/11792