Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2025-12-24 @ 12:14 PM
NCT ID:
NCT00851461
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT00851461
Study Brief:
Protocol Section:
NCT00851461