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Clinical Trials/NCT00851461
NCT00851461CompletedPhase 4

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

Ramathibodi Hospital2 sites in 1 country10 target enrollmentStarted: April 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
muscle power
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

muscle power

Time Frame: every 3 months

Secondary Outcomes

  • electrophysiologic study (Nerve conduction and Electromyogram)(every 3 months)

Investigators

Sponsor Class
Other

Study Sites (2)

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Effect of Goserelin (Zoladex®) in Spinal... | Clinical Trial