Comparison of efficacy and tolerability of rapid intravenous infusion of levetiracetam and sodium valproat. - Levetiracetam i.v.

• Conditions: Focal epilepsy requiring rapid initiation of anticonvulsant protection; MedDRA version: 8.1Level: LLTClassification code 10034061Term: Partial epilepsy, without mention of impairment of consciousness

• Registration Number: EUCTR2006-000869-11-DE
• Lead Sponsor: euro-Consil GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>Primary endpoints of tolerability are all unexpected events actively reported by the patient and serious unexpected events<br>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.<br><br>