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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851461

Enrollment

Registered

2009-02-26

Start date

2008-04-30

Completion date

2013-11-30

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kennedy's Disease, Spinobulbar Muscular Atrophy

Keywords

Spinobulbar muscular atrophy, Kennedy's disease, Goserelin, Electrophysiologic study, Inclusion body

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

Interventions

DRUGGoserelin

Goserelin 10.8 mg SC every 3 months

PROCEDUREElectrophysiologic study

Nerve conduction study Electromyogram

PROCEDUREtissue biopsy

skin and muscle biopsy before and after treatment every year

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
muscle power	every 3 months

Secondary

Measure	Time frame
electrophysiologic study (Nerve conduction and Electromyogram)	every 3 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026