Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures - open label extension study with eslicarbazepine acetate

Phase 1

• Conditions: Adult patients with recently diagnosed partial-onset seizures; MedDRA version: 21.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001243-36-IT
• Lead Sponsor: BIAL-PORTELA & Cª, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-19
• Study Start: 2021-02-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study):
1. Participated in the preceding double-blind study and were still ongoing at the time of unblinding.
2. Have signed informed consent before undergoing any activities related to the open-label extension study.
3. Demonstrated cooperation and willingness to complete all aspects of the study.
4. Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 279
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

Subjects having any of the following at Visit 1 are to be excluded from the study:
1. Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double blind study.
2. Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study.
3. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide- Severity Rating Scale (C-SSRS).
4. Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study.
5. Events of alcohol, drug, or medication abuse during the preceding double-blind study.
6. Relevant clinical laboratory abnormalities (e.g. sodium <125 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (as reported at Visit 1).
7. Pregnancy or lactating.
8. Any oth r condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the extension-study protocol.

Study & Design

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