Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
NCT ID: NCT00851461
Last Updated: 2015-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2008-04-30
2013-11-30
Brief Summary
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Objective:
1. To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
2. To demonstrate physiological and pathological changes in treated patients with Goserelin.
3. To assess tolerability and adverse effect of Goserelin therapy
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Goserelin
Goserelin 10.8 mg SC every 3 months
Electrophysiologic study
Nerve conduction study Electromyogram
tissue biopsy
skin and muscle biopsy before and after treatment every year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males, age over 20 years, undesired fertility
3. Have positive family history of muscle weakness with these clinical signs:
* bulbar involvement (difficulty in breathing, swallowing, talking)
* muscle atrophy with or without fasciculation
* decrease or normal deep tendon reflex
* normal Babinski response
* no sensory impairment
* mild tremor (either postural or intention)
* gynecomastia
* decrease libido and infertility
4. Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.
Exclusion Criteria
2. Have currently prostatic cancer
3. Want to have a child
4. Participation in a clinical study during the last 30 days.
5. Females and children age \< 20 years old
20 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Ramathibodi Hospital
OTHER
Responsible Party
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Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand
Principal Investigators
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Thanyachau Sura, M.D., MRCP
Role: PRINCIPAL_INVESTIGATOR
Ramathibodi Hospital
Locations
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Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Bangkok, Bangkok, Thailand
Countries
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Other Identifiers
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ID11-50-17
Identifier Type: -
Identifier Source: org_study_id
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