Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2025-12-27 @ 9:51 PM
Study NCT ID:
NCT00851461
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2009-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055534', 'term': 'Bulbo-Spinal Atrophy, X-Linked'}], 'ancestors': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017273', 'term': 'Goserelin'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle power', 'timeFrame': 'every 3 months'}], 'secondaryOutcomes': [{'measure': 'electrophysiologic study (Nerve conduction and Electromyogram)', 'timeFrame': 'every 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinobulbar muscular atrophy', "Kennedy's disease", 'Goserelin', 'Electrophysiologic study', 'Inclusion body'], 'conditions': ['Spinobulbar Muscular Atrophy', "Kennedy's Disease"]}, 'descriptionModule': {'briefSummary': 'This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA\n\nObjective:\n\n1. To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand\n2. To demonstrate physiological and pathological changes in treated patients with Goserelin.\n3. To assess tolerability and adverse effect of Goserelin therapy'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent\n2. Males, age over 20 years, undesired fertility\n3. Have positive family history of muscle weakness with these clinical signs:\n\n * bulbar involvement (difficulty in breathing, swallowing, talking)\n * muscle atrophy with or without fasciculation\n * decrease or normal deep tendon reflex\n * normal Babinski response\n * no sensory impairment\n * mild tremor (either postural or intention)\n * gynecomastia\n * decrease libido and infertility\n4. Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.\n\nExclusion Criteria:\n\n1. Have weakness caused by other etiologies and have liver or kidney disease.\n2. Have currently prostatic cancer\n3. Want to have a child\n4. Participation in a clinical study during the last 30 days.\n5. Females and children age \\< 20 years old'}, 'identificationModule': {'nctId': 'NCT00851461', 'briefTitle': 'Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients', 'orgStudyIdInfo': {'id': 'ID11-50-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Goserelin', 'type': 'DRUG', 'otherNames': ['Zoladex LA'], 'description': 'Goserelin 10.8 mg SC every 3 months'}, {'name': 'Electrophysiologic study', 'type': 'PROCEDURE', 'otherNames': ['NCV', 'EMG'], 'description': 'Nerve conduction study Electromyogram'}, {'name': 'tissue biopsy', 'type': 'PROCEDURE', 'description': 'skin and muscle biopsy before and after treatment every year'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Thanyachau Sura, M.D., MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dean of Ramathibodi Hospital', 'oldOrganization': 'Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand'}}}}