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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851461
First Posted: February 26, 2009
Last Update Posted: May 21, 2015
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.
Collaborator:
AstraZeneca
Information provided by:
Ramathibodi Hospital
  Purpose

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 Intervention Phase
Spinobulbar Muscular Atrophy Kennedy's Disease Drug: Goserelin Procedure: Electrophysiologic study Procedure: tissue biopsy Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

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

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

Enrollment: 10
Study Start Date: April 2008
Study Completion Date: November 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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
Thailand
Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
AstraZeneca
Investigators
Principal Investigator: Thanyachau Sura, M.D., MRCP Ramathibodi Hospital
  More Information

Responsible Party: Dean of Ramathibodi Hospital, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand
ClinicalTrials.gov Identifier: NCT00851461     History of Changes
Other Study ID Numbers: ID11-50-17
First Submitted: February 25, 2009
First Posted: February 26, 2009
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:
Atrophy
Muscular Atrophy
Muscular Disorders, Atrophic
Bulbo-Spinal Atrophy, X-Linked
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Muscular Atrophy, Spinal
Spinal Cord Diseases
Central Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Motor Neuron Disease
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents