EUCTR2018-002747-29-PT
Active, not recruiting
Phase 1
Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bial - Portela & Ca, S.A.
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet ALL of the following criteria:
- •1\. Male or female patient aged 18 years or above.
- •2\. To have one of the following confirmed by magnetic resonance
- •imaging (MRI)/computed tomography (CT):
- •a. Acute ischaemic or intracerebral haemorrhagic stroke with
- •\- an acute symptomatic seizure until 120 hours post\-stroke and
- •\- cerebral cortex involvement OR
- •b. Acute ischaemic stroke with
- •\- National Institutes of Stroke Scale (NIHSS) \= 11 and
- •\- cerebral cortex involvement and
Exclusion Criteria
- •Patients are to be excluded from the trial for ANY ONE of the following reasons:
- •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.
- •2\. Known Han Chinese or Thai ancestry.
- •3\. History of previous clinical cerebral cortical (other than the one described in inclusion criteria no. 2 \- 3\) within the last two years prior to Visit 1a.
- •4\. Sinus venous thrombosis.
- •5\. Spontaneous sub\-arachnoid haemorrhage due to e.g. aneurysmatic or arteriovenous malformation.
- •6\. History of USs prior to primary (index) 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 within the last 2 years as defined in the list of not allowed AEDs.
- •9\. Use of ESL, unless provided as IMP of this trial, and oxcarbazepine.
Outcomes
Primary Outcomes
Not specified
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