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

This study has been completed.

Sponsor:

Collaborator:

Ohio State University

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004771

First received: February 24, 2000

Last updated: June 23, 2005

Last verified: December 2001

History of Changes

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

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Spinal Muscular Atrophy

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Testosterone undecanoate Leuprolide acetate

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

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 23, 2016

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