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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ramathibodi Hospital
• Collaborator: AstraZeneca
• Treatments: Goserelin

Criteria

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