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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT03457961
Eligibility Criteria:
Inclusion Criteria:
1. Subject aged 12 years or above
2. Subject has a diagnosis of epilepsy with simple partial seizure and/or complex partial seizures
3. Subjects who have a baseline seizure rate of more than 2 per month in the eight week period preceding the start of AMPA / NMDA receptor antagonist
4. No seizure free period longer than 21 days during the eight week period before AMPA receptor antagonist was started
5. Patients who already had neuropsychiatric inventory completed twice during the treatment period spanning at least 16 weeks.
Exclusion Criteria:
1. Subjects with idiopathic generalised epilepsy (for example, juvenile myoclonic epilepsy and absence epilepsy)
2. Patients who only suffer from isolated auras
3. Baseline creatinine clearance of less than 50ml/min
4. Severe hepatic impairment with ALT three times the upper limits of normal
5. Significant psychiatric conditions before the start of AMPA / NMDA receptor antagonist
6. Progressive neurodegenerative conditions
7. Active history of malignancy
8. History of severe haematological conditions or serious blood dyscrasias
9. Corrected QT interval more than 450 milli-second on ECG
10. Substance abuse
11. Pregnancy, breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03457961
Study Brief:
Protocol Section:
NCT03457961