Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
|
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. |
| ClinicalTrials.gov Identifier: NCT00004771 |
|
Recruitment Status
:
Completed
First Posted
: February 25, 2000
Last Update Posted
: June 24, 2005
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy | Drug: leuprolide Drug: testosterone | Phase 2 |
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 (Clinical Trial) |
| Enrollment : | 40 participants |
| Primary Purpose: | Treatment |
| Study Start Date : | October 1992 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004771
| Study Chair: | Jerry R. Mendell | Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00004771 History of Changes |
| Other Study ID Numbers: |
199/11792 OSU-92H0325 |
| First Posted: | February 25, 2000 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | December 2001 |
Keywords provided by Office of Rare Diseases (ORD):
|
amyotrophic lateral sclerosis motor neuron disease neurologic and psychiatric disorders rare disease |
spinal and bulbar muscular atrophy spinal muscular atrophy Kennedy's Syndrome |
Additional relevant MeSH terms:
|
Motor Neuron Disease Muscular Disorders, Atrophic Pathological Conditions, Anatomical Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases Metabolic Diseases Muscular Diseases Musculoskeletal Diseases Sclerosis Atrophy Amyotrophic Lateral Sclerosis Muscular Atrophy |
Muscular Atrophy, Spinal Pathologic Processes TDP-43 Proteinopathies Proteostasis Deficiencies Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Leuprolide Androgens Hormones |