Multicenter, comparative, randomized, open trial to evaluate efficacy and safety of Levetiracetam versus Carbamazepine in post stroke late onset crisis - ND

• Conditions: Post stroke late onset epileptic crisis; MedDRA version: 8.1Level: LLTClassification code 10054859Term: Myoclonic epilepsy

• Registration Number: EUCTR2006-004355-38-IT
• Lead Sponsor: ASSOCIAZIONE S.N.O.- SCIENZE NEUROLOGICHE OSPEDALIERE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Patients having a stroke ischemic and haemorrhagic showing one subsequent seizure 14 days up to 3 years after stroke Patients has signed the informed consent form 3 aged 8805; 18 years
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

Severe stroke patients with Rankin scale 3 Patients with a life expectancy of 12 months Patients screened more than 15 days after first seizure Patients with a diagnosed epilepsy Patients with clear evidence of myoclonic seizures Patients with contraindication to levetiracetam and carbamazepine use Patients presenting status epilepticus at onset Patients having a MMSE 24 Patients having a seizure before stroke Patients taking any AED 4 weeks prior to randomisation in the study Patients showing dysfagia after stroke not able to swallow tablets. Patients with a low compliance for the study Pregnant women, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method. Allergy or intolerance to pyrrolidine derivatives and/or tablet excipients or to carbamazepine derivates and /or tablet excipients Patients involved in another clinical trial 30 days prior randomization Patients with any tumour Patients with previous traumatic brain accident resulting in impairment of consciousness. Patients for whom it is not possible to assess seizure onset

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate efficacy of Levetiracetam versus Carbamazepine intended as the number of patients free of crisis during the whole treatment period.;Secondary Objective: To compare retention time of LEV vs CBZ since first intake throughout treatment period To compare time to second seizure in both treatments. To evaluate differences in cognitive function and in quality of life in levetiracetam and carbamazepine patients having post-stroke seizures at the end of treatment period To evaluate EEG changes as compared with baseline with that obtained at the end of treatment period To compare seizure frequency in levetiracetam and carbamazepine groups throughout treatment period. To evaluate the safety of levetiracetam versus carbamazepine throughout the treatment period;Primary end point(s): number of patients free from post stroke recurrent crisis