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

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004771
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  Purpose

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 Intervention Phase
Spinal Muscular Atrophy
Amyotrophic Lateral Sclerosis
Spinobulbar Muscular Atrophy
Drug: leuprolide
Drug: testosterone
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 40
Study Start Date: October 1992
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004771

Sponsors and Collaborators
Ohio State University
Investigators
Study Chair: Jerry R. Mendell Ohio State University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004771     History of Changes
Other Study ID Numbers: 199/11792, OSU-92H0325
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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:
Amyotrophic Lateral Sclerosis
Muscular Atrophy
Muscular Atrophy, Spinal
Sclerosis
Motor Neuron Disease
Atrophy
Muscular Disorders, Atrophic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Androgens
Hormones

ClinicalTrials.gov processed this record on July 23, 2014