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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Amyotrophic Lateral Sclerosis; Spinal Muscular Atrophy; Spinobulbar Muscular Atrophy

Treatments: Drug: testosterone; Drug: leuprolide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004771

OSU-92H0325

199/11792

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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