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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00851461 (opens ClinicalTrials.gov in a new tab)Other idID11-50-17
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
10 participants (actual)
Sponsor
Ramathibodi Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Thailand

Start
Apr 2008
Primary completion
Nov 2011
Completion
Nov 2013
First posted
26 Feb 2009 (estimated)
Last update posted
21 May 2015 (estimated)
Conditions
Spinobulbar Muscular Atrophy · Kennedy's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011201220132014
  1. Ph 4

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

    NCT00851461

    Apr 2008 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • GoserelinDrug
  • Electrophysiologic studyProcedure
  • tissue biopsyProcedure

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. muscle power

    Time frame · every 3 months

Secondary outcomes(1)

  1. electrophysiologic study (Nerve conduction and Electromyogram)

    Time frame · every 3 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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