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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00175851
Eligibility Criteria:
Inclusion Criteria:
* A signed and dated IRB/IEC approved written informed consent form
* Male/female age 18 years (16 years where permitted) to 65 years
* Minimum body weight of 40 kg
* Patients having participated in a previous seletracetam study
* Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.
Exclusion Criteria:
* Ongoing psychiatric disease other than mild controlled disorders
* Subject with clinically significant abnormalities in laboratory tests or ECG
* Poor compliance with visit schedule or medication intake in a previous seletracetam study
* Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00175851
Study Brief:
Protocol Section:
NCT00175851