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Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851461
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Ramathibodi Hospital

Study Description
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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 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

Condition or disease Intervention/treatment Phase
Spinobulbar Muscular Atrophy Kennedy's Disease Drug: Goserelin Procedure: Electrophysiologic study Procedure: tissue biopsy Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Goserelin
    Goserelin 10.8 mg SC every 3 months
    Other Name: Zoladex LA
  • Procedure: Electrophysiologic study
    Nerve conduction study Electromyogram
    Other Names:
    • NCV
    • EMG
  • Procedure: tissue biopsy
    skin and muscle biopsy before and after treatment every year

Outcome Measures
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Primary Outcome Measures :
  1. muscle power [ Time Frame: every 3 months ]

Secondary Outcome Measures :
  1. electrophysiologic study (Nerve conduction and Electromyogram) [ Time Frame: every 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent
  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:

  1. Have weakness caused by other etiologies and have liver or kidney disease.
  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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Thailand
Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
AstraZeneca
Investigators
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Principal Investigator: Thanyachau Sura, M.D., MRCP Ramathibodi Hospital
More Information
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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
Keywords provided by Ramathibodi Hospital:
Spinobulbar muscular atrophy
Kennedy's disease
Goserelin
Electrophysiologic study
Inclusion body
Additional relevant MeSH terms:
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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