Focal epilepsy requiring rapid initiation of anticonvulsant protection MedDRA version: 8.1 Level: LLT Classification code 10034061 Term: Partial epilepsy, without mention of impairment of consciousness
Conditions
Interventions
Trade Name: Levetiracetam / Keppra
Product Name: Levetiracetam / Keppra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Levetiracetam
Concentration unit: mg/ml milligra
Sponsors
Neuro-Consil GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women, 18-80 years of age - Diagnosis of epilepsy according to criteria of the International League Against Epilepsy - occurrence of one epileptic seizure if patient and neurologist consider anticonvulsant protection necessary - patients treated with no, one or two anticonvulsants, benzodiazepine emergency medication may be applied additionally prior to the study - patients must be able to understand and comply with the study protocol and fill out a seizure diary Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - patients having participated in another clinical trial within last 2 weeks prior to the study - patients unable to understand patient's information and give informed consent - pregnant or breast-feeding women - treatment with levetiracetam or valproic acid within last 2 weeks prior to the study. - patients being treated with more than 200 mg Lamotrigine/d -patients with a known hypersensitivity or severe unexpected events during prior treatment with either levetiracetam or valproic acid - patients with a history of pseudo-seizures - patients with a history of status epilepticus - women who do not practice a reliable method of birth control - patients suffering any severe, progressive or potentially life-threatening disease - patients with clinically important impairment of renal, pancreatic or hepatic function - patients with a history of alcoholism or drug abuse - patients with a severe psychiatric disease, especially when suicidal. Exception: Mild or medium degree depression without suicidal tendency or history of attempted suicide - patients with abnormal laboratory evaluations if considered clinically significant by the investigator - patients who are dependent on the sponsor or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide preliminary data on the efficacy and safety of rapid intravenous infusion of levetiracetam (Keppra);Secondary Objective: To compare the efficacy and safety of rapid intravenous infusion of levetiracetam (Keppra) to that of Valproic acid;Primary end point(s): Primary endpoints of this proof of concept study are descriptive statistics of efficacy and tolerability. Primary endpoints of efficacy are seizure days, seizure frequency and fraction of totally seizure-free patients during the initial 4 days period of titration or the entire 14 days of the study. Primary endpoints of tolerability are all unexpected events actively reported by the patient and serious unexpected events Primary combined endpoint of efficacy and tolerability is the number of patients completing the trial, either during the initial 4 days period of titration or during the entire 14 days. | — |
Countries
Germany
Outcome results
None listed