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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00004771
Date of registration: 24/02/2000
Prospective Registration: No
Primary sponsor: National Center for Research Resources (NCRR)
Public title: Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
Scientific title:
Date of first enrolment: October 1992
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004771
Study type:  Interventional
Study design:  Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Contacts
Name:     Jerry R. Mendell
Address: 
Telephone:
Email:
Affiliation:  Ohio State University
Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Spinal Muscular Atrophy
Spinobulbar Muscular Atrophy
Intervention(s)
Drug: leuprolide
Drug: testosterone
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
199/11792
OSU-92H0325
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ohio State University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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