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

NCT00851461 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-05-21

No results posted yet for this study

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

Conditions

  • Spinobulbar Muscular Atrophy
  • Kennedy's Disease

Interventions

DRUG

Goserelin

Goserelin 10.8 mg SC every 3 months

PROCEDURE

Electrophysiologic study

Nerve conduction study Electromyogram

PROCEDURE

tissue biopsy

skin and muscle biopsy before and after treatment every year

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Thanyachau Sura, M.D., MRCP · Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-11-30
Completion
2013-11-30

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00851461 on ClinicalTrials.gov