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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT01422720
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent form;
2. Of age 65 years or older;
3. A documented diagnosis of epilepsy for at least 12 months,
4. At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
5. Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
6. Willing and able to comply with all trial requirements, in the judgment of the investigator;
7. At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
8. Satisfactorily complied with the study requirements during the baseline period
Exclusion Criteria:
1. Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
2. Primarily generalised seizures;
3. Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
4. Occurrence of seizures too close to count accurately;
5. History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
6. Seizures of non-epileptic origin;
7. Major psychiatric disorders;
8. History of suicide attempt;
9. Currently treated with oxcarbazepine;
10. Previous use of ESL or participation in a clinical study with ESL;
11. Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
13. Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
14. Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium \<130 mmol/L, alanine or aspartate aminotransferases \>2.0 times above the upper limit of the range, or white blood cell count \<3,000 cells/mm3;
15. Calculated creatinine values \< 30 mL/min at screening;
16. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
17. Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01422720
Study Brief:
Protocol Section:
NCT01422720