prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate - prophylaxis of post-stroke epilepsy

Bial - Portela & Ca, S.A0 sites220 target enrollmentApril 17, 2019

ConditionsProphylaxis of epilepsy following stroke MedDRA version: 20.0 Level: PT Classification code 10076982 Term: Post stroke epilepsy System Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsEslicarbazepine Acetate

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prophylaxis of epilepsy following stroke
Sponsor: Bial - Portela & Ca, S.A
Enrollment: 220
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 17, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Bial - Portela & Ca, S.A

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patient aged 18 years or above.
•2\. Acute intracerebral haemorrhage with a CAVE score \= 3 or acute ischaemic stroke with a SeLECT score \= 6, in each case confirmed by magnetic resonance imaging (MRI)/computed tomography (CT).
•3\. Time of stroke occurrence is known and V1b is planned within 96 hours.
•4\. Brain scan analysis has reliably excluded structural brain lesions that can mimic stroke, e.g. cerebral tumour or brain abscess, etc.
•5\. a. Patient is able to give informed consent and to write and has signed written informed consent OR
•b. Patient is able to give informed consent, but unable to write and has provided verbal witnessed consent OR
•c. Patient is unable to give informed consent, but likely to regain this ability until V2, and the informed consent is deferred OR
•d. Patient is unable to give informed consent, but likely to regain this ability until V2, and patient’s legal representative (according to the respective national/local requirements) has provided written informed consent.
•6\. Female patients without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female patients with childbearing potential must not be pregnant as confirmed by a negative pregnancy test and sexually active females must use a medically acceptable effective nonhormonal method of contraception up to the end of the current menstrual cycle after stopping treatment. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), intrauterine device, double\-barrier methods, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised male partner, provided that he is the sole partner of that patient.
•Periodic abstinence (e.g., calendar, ovulation, symptothermal, post\-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria

•1\. Contraindication to ESL, i.e. known hypersensitivity to ingredients of ESL formulation or other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine), or second or third degree atrioventricular (AV) block not corrected with a permanent pacemaker.
•2\. Known Han Chinese or Thai ancestry.
•3\. History of previous stroke (other than the one described in inclusion criteria no. 2 \- 3\).
•4\. Sinus venous thrombosis.
•5\. Spontaneous sub\-arachnoid haemorrhage due to e.g. aneurysmatic or arteriovenous malformation.
•6\. History of USs prior to primary stroke.
•7\. Impaired pre\-stroke level of function, i.e. modified Rankin Scale (mRS) score \> 3 prior to first stroke occurrence.
•8\. History of AED use before primary stroke within the last 5 years as defined in the list of not allowed AEDs.
•9\. Use of ESL, unless provided as IMP of this trial, and oxcarbazepine.
•10\. Severe hepatic impairment.