EUCTR2018-002747-29-PT进行中（未招募）1 期
Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •- large-artery atherosclerosis and/or territory of middle cerebral artery
- •c. Acute ischaemic stroke with
- •- NIHSS 4-10 and
- •- cerebral cortex involvement and
- •- large-artery atherosclerosis and
- •- territory of MCA OR
- •d. Acute intracerebral haemorrhagic stroke with
- •- cerebral cortex involvement and
- •- volume of intracerebral haemorrhage > 10 mL.
- •3. Time of stroke occurrence is known and V1b is planned within 120
- •hours since the known time of stroke occurrence, or since last time seen
- •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 * NOT applicable in Portugal [Text which is NOT applicable in Portugal is displayed in italics.] OR
- •d. Patient is unable to give informed consent, but likely to regain this ability until V2 * NOT applicable in Portugal [Text which is NOT applicable in Portugal is displayed in italics.] , 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 non-hormonal 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.
- •The requirements of the relevant ethics committees must be adhered to at all times. Written or verbal witnessed informed consent from the patient must be obtained until V2 – not applicable for Portugal.
- •Inclusion criteria at V1b
- •7. V1b is within 120 hours after stroke, or since last time seen well.
- •Inclusion criteria at V2 (only applicable for patients who were unable to give informed consent at V1a.)*
- •8. a. Patient is able to give informed consent and to write and has signed a written informed consent *OR
- •b. Patient is able to give informed consent, but unable to write and has provided verbal witnessed consent.*
- •* NOT applicable in Portugal [Text which is NOT applicable in Portugal is displayed i
排除标准
- •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.
- •10. Severe hepatic impairment.
- •11. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1a).
- •12. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis.
- •13. History of suicidal ideation or suicide attempt within the past 3 years.
- •14. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the trial treatment or may jeopardise the patient’s safety, compliance or adherence to protocol requirements, such as significant psychiatric, cardiovascular, respiratory, metabolic, endocrine, haematologic, infectious or neurological disease.
- •15. For women: Pregnancy or breast-feeding.
- •16. Previous enrolment in this trial or participation in any other investigational drug trial within the past 30 days (or 5 half-lives of IMP whichever is longer) prior to V1a.
- •17. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- •18. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the investigator.
研究者
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