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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

Tracking Information
First Submitted Date  ICMJE February 25, 2009
First Posted Date  ICMJE February 26, 2009
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE April 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
muscle power [ Time Frame: every 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00851461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
electrophysiologic study (Nerve conduction and Electromyogram) [ Time Frame: every 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
Official Title  ICMJE Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinobulbar Muscular Atrophy
  • Kennedy's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2009)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851461
Other Study ID Numbers  ICMJE ID11-50-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dean of Ramathibodi Hospital, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand
Study Sponsor  ICMJE Ramathibodi Hospital
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Thanyachau Sura, M.D., MRCP Ramathibodi Hospital
PRS Account Ramathibodi Hospital
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP