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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00391534
Eligibility Criteria:
Inclusion Criteria:
* Female and male patients with minimal age of 18 years on the date of the first study visit.
* Stable treatment with Oxcarbazepine treatment (Timox® /Trileptal®), dosage: exactly 900 mg or exactly 1200 mg or exactly 1500 mg for at least 1 month prior to screening.
* \>= 2 partial onset seizures with or without secondary generalisation refractory to existing AED therapy within the baseline period.
* Weight between \>= 50 kg and \< 100 kg.
* for females with child-bearing potential: negative pregnancy rest and highly effective form of birth control (females using hormonal contraceptives should use a different or additional means of birth control, e.g. IUD, abstinence, vasectomized partner, double barriere methods with or without oral contraceptives)
* Stable regimen of \<= 2 concomitant AEDs (vagus nerve stimulator included) during the baseline period; lamotrigine dose may be adjusted at baseline.
* Ethnic origin: Caucasian.
* Subjects capable of complying with the study stipulations.
* Patients who have provided written informed consent to participate in this study.
Exclusion Criteria:
* Epilepsy secondary to progressive metabolic disease, malignant neoplasm, substance abuse, or active infection.
* Status epilepticus at any time during the baseline period.
* Lennox-Gastaut syndrome.
* Generalized epilepsy as primary diagnosis.
* Severe cardiac, pulmonary, haematological, hepatic, renal or neoplastic pathology.
* Acute medical conditions and/or conditions that could interfere with the absorption, metabolism or excretion of oxcarbazepine.
* History of clinically relevant psychiatric illness and/or drug abuse, drug addiction or alcoholism within the last 2 years.
* Treatment with psychotropic drugs, anticholinergic drugs, anti-parkinson medication, α1-antagonists, α2-antagonists, carbamazepine, topiramate, felbamate, vigabatrin. Stable treatment with selective serotonin-reuptake-inhibitor (SSRI) having been given for at least 4 weeks prior to screening as supportive treatment of partial epilepsy can be accepted.
* Intake of sodium lowering medication, e.g. diuretics and non-steroidal anti- inflammatory drugs. Occasional and short-term intake of non-steroidal anti- inflammatory drugs on demand (Ibuprofen, Paracetamol, ASS, Diclofenac and others) is allowed.
* Hypersensitivity towards oxcarbazepine or chemically related drugs.
* Low sodium serum levels (\< 128 mmol/L). Sodium serum levels ≥ 126 and \< 128 mmol/L can be accepted for inclusion, if these levels have been stable for at least 3 months.
* Symptomatic hyponatremia.
* Pregnancy or breast feeding.
* Participation in drug trials during 3 months preceding the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00391534
Study Brief:
Protocol Section:
NCT00391534