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

National Center for Research Resources (NCRR)40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy

Interventions

leuprolideDRUG

testosteroneDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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