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 on February 24, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	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

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 Leuprolide Leuprolide acetate Oxymesterone Testosterone enanthate Testosterone undecanoate

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
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

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:

Amyotrophic Lateral Sclerosis
Muscular Atrophy
Muscular Atrophy, Spinal
Sclerosis
Motor Neuron Disease
Atrophy
Muscular Disorders, Atrophic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases

Neuromuscular Manifestations
Neurologic Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Androgens
Hormones

ClinicalTrials.gov processed this record on February 12, 2012