Preventive treatment of stroke patients with eslicarbazepine acetate to prevent development of epilepsy

Phase 1

• Conditions: Prophylaxis 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]

• Registration Number: EUCTR2018-002747-29-GB
• Lead Sponsor: Bial - Portela & Ca, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 220

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.
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.
Inclusion criteria at V1b
7. V1b is within 96 hours after stroke occurrence.
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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

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.
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.

Study & Design

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