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NCT00004771 Clinical Trial

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

Amyotrophic Lateral Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004771
Other study ID # 199/11792
Secondary ID OSU-92H0325
Status Completed
Phase Phase 2
First received February 24, 2000
Last updated June 23, 2005
Start date October 1992

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• leuprolide

• testosterone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Ohio State University
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