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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01002820
Eligibility Criteria:
Inclusion Criteria:
* subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
* having had no major adverse events thought to be drug related
* deriving benefit from ganaxolone treatment
* be properly informed of the nature and risks of the study and give written informed consent prior to study entry
* must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test
Exclusion Criteria:
* significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
* unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
* history of chronic non-compliance with drug regimens
* females currently breastfeeding
* AST or ALT levels greater than 3 times the upper limit of normal at screen
* Inability to withhold grapefruit or grapefruit products during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01002820
Study Brief:
Protocol Section:
NCT01002820