Status:
COMPLETED
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
Lead Sponsor:
Ramathibodi Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Spinobulbar Muscular Atrophy
Kennedy's Disease
Eligibility:
MALE
20+ years
Phase:
PHASE4
Brief Summary
This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA Objective: 1. To study effects of Goserelin to clinical course of patients with spinal and bulb...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Males, age over 20 years, undesired fertility
- 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
- Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.
Exclusion
- Have weakness caused by other etiologies and have liver or kidney disease.
- Have currently prostatic cancer
- Want to have a child
- Participation in a clinical study during the last 30 days.
- Females and children age \< 20 years old
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00851461
Start Date
April 1 2008
End Date
November 1 2013
Last Update
May 21 2015
Active Locations (1)
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1
Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Bangkok, Bangkok, Thailand, 10400