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

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ClinicalTrials.gov Identifier: NCT00004771
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Ohio State University
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy Drug: leuprolide Drug: testosterone Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Primary Purpose: Treatment
Study Start Date : October 1992

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004771


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Ohio State University
Investigators
Study Chair: Jerry R. Mendell Ohio State University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00004771     History of Changes
Other Study ID Numbers: 199/11792
OSU-92H0325
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001

Keywords provided by Office of Rare Diseases (ORD):
amyotrophic lateral sclerosis
motor neuron disease
neurologic and psychiatric disorders
rare disease
 spinal and bulbar muscular atrophy
spinal muscular atrophy
Kennedy's Syndrome

Additional relevant MeSH terms:
Motor Neuron Disease
Muscular Disorders, Atrophic
Pathological Conditions, Anatomical
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Sclerosis
Atrophy
Amyotrophic Lateral Sclerosis
Muscular Atrophy
 Muscular Atrophy, Spinal
Pathologic Processes
TDP-43 Proteinopathies
Proteostasis Deficiencies
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Androgens
Hormones