Spinobulbar Muscular AtrophyPhase 4NCT00851461
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
A Phase 4 study testing Goserelin, Electrophysiologic study and tissue biopsy in people with Spinobulbar Muscular Atrophy and Kennedy's Disease, run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Spinobulbar Muscular Atrophy, Kennedy's Disease
- What is being tested?
- Goserelin, Electrophysiologic study and tissue biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2008to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Bangkok, Bangkok, 10400
About this study
Official title: Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA
Objective:
- To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
- To demonstrate physiological and pathological changes in treated patients with Goserelin.
- To assess tolerability and adverse effect of Goserelin therapy
- Conditions
- Spinobulbar Muscular Atrophy, Kennedy's Disease
- Being tested
- Goserelin, Electrophysiologic study, tissue biopsy
- Keywords
- Spinobulbar muscular atrophy, Kennedy's disease, Goserelin, Electrophysiologic study, Inclusion body
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
Also called Zoladex LA
Goserelin 10.8 mg SC every 3 months
Electrophysiologic studyProcedure or surgery
Also called NCV, EMG
Nerve conduction study Electromyogram
tissue biopsyProcedure or surgery
skin and muscle biopsy before and after treatment every year
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle power
Measured: every 3 months
Secondary outcomes (1)
electrophysiologic study (Nerve conduction and Electromyogram)
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionNov 2011
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinobulbar Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Thanyachau Sura, M.D., MRCP, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851461
- Sponsor's protocol ID
- ID11-50-17
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
- ClinicalTrials.gov ID
- NCT00851461
- Acronym / sponsor ID
- ID11-50-17
- Conditions
- Spinobulbar Muscular Atrophy, Kennedy's Disease
- Keywords
- Spinobulbar muscular atrophy, Kennedy's disease, Goserelin, Electrophysiologic study, Inclusion body
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA
Objective:
- To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
- To demonstrate physiological and pathological changes in treated patients with Goserelin.
- To assess tolerability and adverse effect of Goserelin therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of informed consent
- Males, age over 20 years, undesired fertility
- Have positive family history of muscle weakness with these clinical signs:
- Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoserelinAlso: Zoladex LAGoserelin 10.8 mg SC every 3 months | Drug | – |
| Electrophysiologic studyAlso: NCV, EMGNerve conduction study Electromyogram | Procedure or surgery | – |
| tissue biopsyskin and muscle biopsy before and after treatment every year | Procedure or surgery | – |
Primary outcome
muscle power
Time frame: every 3 months
1 secondary outcome
electrophysiologic study (Nerve conduction and Electromyogram)
Time frame: every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanyachau Sura, M.D., MRCP principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Goserelin, Electrophysiologic study and tissue biopsy in people with Spinobulbar Muscular Atrophy and Kennedy's Disease, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle power (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.