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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Ohio State University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004771

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 II

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 Leuprolide Leuprolide acetate Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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
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

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

No publications provided

Study ID Numbers:	199/11792, OSU-92H0325
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004771 History of Changes
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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Spinal Cord Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Neurodegenerative Diseases
Hormones
Signs and Symptoms
Neuromuscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Mental Disorders
Muscular Atrophy, Spinal
Leuprolide
Motor Neuron Disease
Degenerative Motor System Disease

Muscular Atrophy
Progressive Spinal Muscular Atrophy
Kennedy Disease
Antineoplastic Agents, Hormonal
Rare Diseases
Spinal Muscular Atrophy
Central Nervous System Diseases
Sclerosis
Methyltestosterone
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Muscular Diseases
Lou Gehrig's Disease
Amyotrophic Lateral Sclerosis

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Spinal Cord Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Neurodegenerative Diseases
Hormones
Signs and Symptoms
Pathologic Processes
Neuromuscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Muscular Atrophy, Spinal
Leuprolide

Therapeutic Uses
Motor Neuron Disease
Muscular Atrophy
Neuromuscular Manifestations
Antineoplastic Agents, Hormonal
Nervous System Diseases
Central Nervous System Diseases
Sclerosis
Methyltestosterone
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Muscular Diseases
Amyotrophic Lateral Sclerosis

ClinicalTrials.gov processed this record on May 07, 2009