Leuprolide and Testosterone Therapy for Kennedy's Disease or Motor Neuron Disease
leuprolide
+ testosterone
Central Nervous System Diseases+21
+ Metabolic Diseases
+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Treatment Study
Summary
Study start date: October 1, 1992
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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