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:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT00423605
Eligibility Criteria:
Inclusion Criteria:
* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
Exclusion Criteria:
* Subject terminated early from either study 06-009 or 06-008.
* Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
* Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00423605
Study Brief:
Protocol Section:
NCT00423605