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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00524134
Eligibility Criteria:
Inclusion Criteria:
* probable or definite localization-related, primary generalized or symptomatic generalized epilepsy that is medically-refractory, as defined by treatment failure of at least 2 anti-epilepsy drugs at standard doses, despite medication compliance as determined by the treating neurologist
* at least 3 seizures/month in the 3-month period prior to randomization. Seizures that will be considered include generalized tonic clonic, complex partial, myoclonic and absence seizures. Simple partial seizures must have an observable motor component or have been otherwise been documented by videoEEG to be a definite seizure.
* Patients with prior epilepsy brain surgery or vagal nerve stimulator implantation will be allowed if medication and seizure frequency has been stable for the prior 3 months.
* Ages between 10 and 75 years will be eligible for inclusion. Elderly patients without a history or symptoms of cardiovascular disease may be eligible on a case-by-case basis. No patients older than 75 will be included due to the possible cardiovascular side-effects.
* Pre-menopausal women must be utilizing two reliable forms of birth control or abstinence
* ability of the patient to understand the concept of a clinical trial by answering the following questions appropriately: o will your seizures get better, worse or stay the same? Response in the spirit of: Any of the 3 could happen.
Exclusion Criteria:
* pregnancy or breast-feeding
* systolic blood pressure \<100mmHg
* resting heart rate \< 55 bpm
* concurrent calcium channel, beta-blocker or digoxin therapy
* Known hypersensitivity to carvedilol or any component of the formulation
* Decompensated cardiac failure requiring intravenous inotropic therapy
* Coronary artery disease with history of angina or Any cause of unstable angina
* Second- or third-degree AV block or sick sinus syndrome
* Bronchial asthma or related bronchospastic conditions
* Severe hepatic or renal impairment
* Active drug or alcohol dependence, that, in the opinion of a study investigator, would interfere with adherence to study requirements
* Any acute medical or psychiatric illness requiring inpatient admission; exceptions are elective epilepsy monitoring or elective procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
75 Years
Study:
NCT00524134
Study Brief:
Protocol Section:
NCT00524134