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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00004771

First Posted: February 25, 2000

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Ohio State University

Information provided by:

Office of Rare Diseases (ORD)

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	Intervention	Phase
Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy	Drug: leuprolide Drug: testosterone	Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis spinal and bulbar muscular atrophy spinal muscular atrophy

Drug Information available for: Testosterone

Genetic and Rare Diseases Information Center resources: Spinal Muscular Atrophy Kennedy Disease Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):


Estimated Enrollment:	40
Study Start Date:	October 1992

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


ClinicalTrials.gov Identifier:	NCT00004771 History of Changes
Other Study ID Numbers:	199/11792 OSU-92H0325
First Submitted:	February 24, 2000
First Posted:	February 25, 2000
Last Update Posted:	December 9, 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

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