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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Ramathibodi Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT00851461
First received: February 25, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Enrollment: 10
Study Start Date: April 2008
Estimated Study Completion Date: November 2011
Estimated 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

Ages Eligible for Study:   20 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 25, 2009
Last Updated: February 25, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:
Spinobulbar muscular atrophy
Kennedy's disease
Goserelin
Electrophysiologic study
Inclusion body

Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Central Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Motor Neuron Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathological Conditions, Anatomical
Spinal Cord Diseases
Atrophy
Bulbo-Spinal Atrophy, X-Linked
Muscular Atrophy
Muscular Atrophy, Spinal
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014