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

• Sponsor: Ramathibodi Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00851461
• Collaborator: AstraZeneca (Industry)
• Enrollment: 10
• Location: 1
• Duration (Months): 67
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Spinobulbar Muscular Atrophy; Kennedy's Disease	Drug: Goserelin; Procedure: Electrophysiologic study; Procedure: tissue biopsy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2013

Outcome Measures

Primary Outcome Measures

1. muscle power [every 3 months]

Secondary Outcome Measures

1. electrophysiologic study (Nerve conduction and Electromyogram) [every 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

• Ramathibodi Hospital
• AstraZeneca

Investigators

• Principal Investigator: Thanyachau Sura, M.D., MRCP, Ramathibodi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00851461
• Other Study ID Numbers: ID11-50-17
• First Posted: Feb 26, 2009
• Last Update Posted: May 21, 2015
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Spinobulbar muscular atrophy; Kennedy's disease; Goserelin; Electrophysiologic study; Inclusion body
• Additional relevant MeSH terms: Muscular Atrophy; Bulbo-Spinal Atrophy, X-Linked; Atrophy; Goserelin

Study Results

No Results Posted as of May 21, 2015