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

• ClinicalTrials.gov Identifier: NCT00851461
• Recruitment Status: Completed
• First Posted: February 26, 2009
• Last Update Posted: May 21, 2015
• Sponsor: Ramathibodi Hospital
• Collaborator: AstraZeneca
• Information provided by: Ramathibodi Hospital

Tracking Information

• First Submitted Date: February 25, 2009
• First Posted Date: February 26, 2009
• Last Update Posted Date: May 21, 2015
• Study Start Date: April 2008
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 25, 2009): muscle power [ Time Frame: every 3 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00851461 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: February 25, 2009): electrophysiologic study (Nerve conduction and Electromyogram) [ Time Frame: every 3 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Spinobulbar Muscular Atrophy
• Kennedy's Disease

Intervention

• 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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2009): 10
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT00851461
• Other Study ID Numbers: ID11-50-17
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dean of Ramathibodi Hospital, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand
• Study Sponsor: Ramathibodi Hospital
• Collaborators: AstraZeneca

Investigators

• Principal Investigator: Thanyachau Sura, M.D., MRCP; Ramathibodi Hospital

• PRS Account: Ramathibodi Hospital
• Verification Date: February 2009