Levetiracetam Versus Carbamazepine in Post-Stroke Late Onset Crisis

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The principal purpose of the study is to determine the efficacy and safety of Levetiracetam versus Carbamazepine, intended as the number of patients free from crisis during the whole period of treatment, in patients affected by post stroke late onset crisis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scienze Neurologiche Ospedaliere
• Treatments: Carbamazepine; Etiracetam; Levetiracetam; Piracetam

Criteria

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

• Aged ≥ 18 years

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 epileptic status 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 dysphagia 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