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Spinocerebellar Atrophy |
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Clinical Trial: Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease
This study has been completed.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy | Drug: leuprolide Drug: testosterone | Phase II |
MedlinePlus related topics: Amyotrophic Lateral Sclerosis; Muscle Disorders; Neuromuscular Disorders; Spinal Muscular Atrophy
Genetics Home Reference related topics: amyotrophic lateral sclerosis; spinal muscular atrophy
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 40
Study start: October 1992
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
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
Location Information
Jerry R. Mendell, Study Chair, Ohio State University
More Information
Record last reviewed: December 2001
Last Updated: October 13, 2004
Record first received: February 24, 2000
ClinicalTrials.gov Identifier: NCT00004771
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Ataxia (National Institute of Neurological Disorders and Stroke)
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