NCT00851461CompletedPhase 4
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ramathibodi Hospital
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- muscle power
Study Overview
Brief Summary
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
- 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
Study Sites (2)
Loading locations...
Similar Trials
Terminated
Phase 3
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast CancerBreast CancerNCT00429403M.D. Anderson Cancer Center1
Unknown
Phase 2
Neoadjuvant Goserelin for Triple Negative Breast CancerBreast Cancer Triple NegativeNCT03444025Kasr El Aini Hospital180
Completed
Phase 2
Goserelin/Letrozole in Premenopausal Patients vs Letrozole Alone in Postmenopausal Patients With MBCMetastatic Breast CancerNCT00532272National Cancer Center, Korea78
Completed
Phase 3
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast CancerMenopausal SymptomsBreast CancerInfertilityNCT00068601SWOG Cancer Research Network257
Terminated
Phase 2
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast CancerEstrogen Receptor-positive Breast CancerHER2-negative Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerNCT01368263Washington University School of Medicine8
