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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT01281956
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Enrolled in protocol 01-N-0139
2. Age 18 to 65
3. Localization-related epilepsy diagnosed by standard clinical criteria that has not responded to treatment with up to two standard antiepileptic drugs either sequentially or in combination.
4. Patients must be able to provide informed consent.
5. Patients must be able to remain on their baseline AED drugs and doses for the duration of the study
6. Patients must be able to use seizure calendars to record seizures throughout the trial.
7. Experiences 4 seizures within a 6-week period
EXCLUSION CRITERIA:
1. Pregnancy or lactation
2. Women of child-bearing potential and men who are unable or unwilling to take adequate contraceptive precautions, including one of the following:
* hormonal contraception (birth control pills, injected hormones or vaginal ring);
* intrauterine device;
* barrier methods (condom or diaphragm) combined with spermicide;
* surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner
3. Current treatment for another significant medical disorder, such as diabetes, or heart disease, or an untreated disorder, that is discovered during the screening examination and might interfere with the study and is determined by the PI to warrant exclusion of the participant.
4. An abnormality on clinical laboratory tests, physical examination, EEG or ECG that might increase the risk associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal, or hematocrit lower than 30.
5. A level 4 or 5 on the Columbia Suicide Severity Rating Scale rating for symptoms during the last month
6. Concomitant treatment with more than 2 AEDs
7. Evidence for a potentially progressive neurologic disorder, such as an astrocytoma
8. Use of sublingual lorazepam for seizure clusters more than once per wee
9. Use of any of the following prohibited medications/classes with less than required interval period:
* Any other Investigational drugs; required interval period (weeks prior to baseline) is 4
* benzodiazepines; required interval period (weeks prior to baseline) is 4
* MAO Inhibitors anti depressant; required interval period (weeks prior to baseline) is 4
* Buspirone; required interval period (weeks prior to baseline) is 2
* other psychotropic medicines; required interval period (weeks prior to baseline) is 2
* potent CYP3A4 inducers/inhibitors; required interval period (weeks prior to baseline) is 2 for:
* Itraconazole
* ketoconazole
* HIV antivirals
* clarithromycin
* phenytoin
* Prornolol is 2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01281956
Study Brief:
Protocol Section:
NCT01281956