Spinal Muscular AtrophyPhase 2NCT00004771
Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
A Phase 2 study testing leuprolide and testosterone in people with Spinal Muscular Atrophy and Amyotrophic Lateral Sclerosis, run by National Center for Research Resources (NCRR).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis, Spinobulbar Muscular Atrophy
- What is being tested?
- leuprolide and testosterone
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 1992to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
About this study
OBJECTIVES:
- 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.
Read the 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.
- Being tested
- leuprolide, testosterone
- Keywords
- amyotrophic lateral sclerosis, motor neuron disease, neurologic and psychiatric disorders, rare disease, spinal and bulbar muscular atrophy, spinal muscular atrophy, Kennedy's Syndrome
- Medical subject headings
- Muscular Atrophy, Spinal, Amyotrophic Lateral Sclerosis, Bulbo-Spinal Atrophy, X-Linked, Motor Neuron Disease, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leuprolideDrug
testosteroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startOct 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Ohio State University
- Investigators
- Jerry R. Mendell, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004771
- Sponsor's protocol ID
- 199/11792
- Other IDs
- OSU-92H0325
- Status last verified
- Dec 2001
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
- ClinicalTrials.gov ID
- NCT00004771
- Acronym / sponsor ID
- 199/11792
- Keywords
- amyotrophic lateral sclerosis, motor neuron disease, neurologic and psychiatric disorders, rare disease, spinal and bulbar muscular atrophy, spinal muscular atrophy, Kennedy's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Ohio State University
- Study start
- Oct 1992
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leuprolide | Drug | – |
| testosterone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry R. Mendell study chair
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing leuprolide and testosterone in people with Spinal Muscular Atrophy and Amyotrophic Lateral Sclerosis, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 7 Nov 2026.