Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
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ClinicalTrials.gov Identifier: NCT00851461 |
Recruitment Status :
Completed
First Posted : February 26, 2009
Last Update Posted : May 21, 2015
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This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA
Objective:
- To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
- To demonstrate physiological and pathological changes in treated patients with Goserelin.
- To assess tolerability and adverse effect of Goserelin therapy
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinobulbar Muscular Atrophy Kennedy's Disease | Drug: Goserelin Procedure: Electrophysiologic study Procedure: tissue biopsy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2013 |

- Drug: Goserelin
Goserelin 10.8 mg SC every 3 monthsOther Name: Zoladex LA
- Procedure: Electrophysiologic study
Nerve conduction study ElectromyogramOther Names:
- NCV
- EMG
- Procedure: tissue biopsy
skin and muscle biopsy before and after treatment every year
- muscle power [ Time Frame: every 3 months ]
- electrophysiologic study (Nerve conduction and Electromyogram) [ Time Frame: every 3 months ]

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: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of informed consent
- Males, age over 20 years, undesired fertility
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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 Criteria:
- 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

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): NCT00851461
Thailand | |
Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital | |
Bangkok, Thailand, 10400 |
Principal Investigator: | Thanyachau Sura, M.D., MRCP | Ramathibodi Hospital |
Responsible Party: | Dean of Ramathibodi Hospital, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand |
ClinicalTrials.gov Identifier: | NCT00851461 |
Other Study ID Numbers: |
ID11-50-17 |
First Posted: | February 26, 2009 Key Record Dates |
Last Update Posted: | May 21, 2015 |
Last Verified: | February 2009 |
Spinobulbar muscular atrophy Kennedy's disease Goserelin Electrophysiologic study Inclusion body |
Muscular Atrophy Bulbo-Spinal Atrophy, X-Linked Atrophy Pathological Conditions, Anatomical Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Muscular Atrophy, Spinal Spinal Cord Diseases Central Nervous System Diseases |
Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Motor Neuron Disease Neuromuscular Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Goserelin Antineoplastic Agents, Hormonal Antineoplastic Agents |