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Completed

NCT Number: NCT00851461

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

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

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Key information

Conditions

Spinobulbar Muscular Atrophy Bulbo-Spinal Atrophy, X-Linked Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Kennedy's Disease Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent
  • Males, age over 20 years, undesired fertility
  • 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
  • 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

  • Have weakness caused by other etiologies and have liver or kidney disease.
  • Have currently prostatic cancer
  • Want to have a child
  • Participation in a clinical study during the last 30 days.
  • Females and children age < 20 years old

Treatment and study plan

Goserelin

Drug

Goserelin 10.8 mg SC every 3 months

Other names: Zoladex LA

Electrophysiologic study

Procedure

Nerve conduction study Electromyogram

Other names: NCV, EMG

Tissue biopsy

Procedure

skin and muscle biopsy before and after treatment every year

Primary outcomes

  1. muscle power

    Time frame: every 3 months

Secondary outcomes

  1. electrophysiologic study (Nerve conduction and Electromyogram)

    Time frame: every 3 months

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Feb 26, 2009
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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