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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004771
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ohio State University
Information provided by:
Office of Rare Diseases (ORD)
February 24, 2000
February 25, 2000
December 9, 2005
October 1992
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No Changes Posted
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Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
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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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Spinal Muscular Atrophy
  • Amyotrophic Lateral Sclerosis
  • Spinobulbar Muscular Atrophy
  • Drug: leuprolide
  • Drug: testosterone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004771
199/11792
OSU-92H0325
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National Center for Research Resources (NCRR)
Ohio State University
Study Chair: Jerry R. Mendell Ohio State University
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP