Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures

NCT02484001 | Completed Phase 3

• 1 other identifier: BIA-2093-311/EXT
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase III, multinational, open-label, non-controlled study with subjects under treatment in the double-blind BIA-2093-311 study (NCT01162460). Subjects will enter the open-label extension study after the preceding double-blind study was unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind study. For all subjects, the day of the last EPV of the double-blind study will also be the day of Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate (ESL) under open-label conditions at Visit 1. The complete study duration including treatment with ESL under open-label conditions and follow-up is expected to last approximately 2 years (105 weeks). In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.

Conditions

Epilepsy

Keywords

Eslicarbazepine acetate; BIA 2-093; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure

  Time to treatment failure, defined as time from start of open-label ESL treatment at Visit 1 until withdrawal due to AE or due to lack of efficacy (i.e. inadequate seizure control), is the primary endpoint of this study. Open-label ESL treatment will be provided for approximately 2 years. Regular Treatment Visits (TVs) will be performed every 3 months after start of treatment.

  up to 2 years

Secondary Outcomes (1)

• Number of Adverse Events (AEs) reported by patient

  participants will be followed for the duration of the clinical trial, an expected average of 2 years

Study Arms (4)

ESL 800 mg

EXPERIMENTAL

ESL will be administered orally once daily (QD)

Drug: ESL 800 mg

ESL 1200 mg

EXPERIMENTAL

ESL will be administered orally once daily (QD)

Drug: ESL 1200 mg

ESL 1600 mg

EXPERIMENTAL

ESL will be administered orally once daily (QD)

Drug: ESL 1600 mg

ESL 400 mg

EXPERIMENTAL

ESL will be administered orally once daily (QD)

Drug: ESL 400 mg

Interventions

ESL 800 mg DRUG

one (1) tablet of 800 mg (QD).

Also known as: BIA 2-093

ESL 800 mg

ESL 1200 mg DRUG

one (1) and a half tablets of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL)

Also known as: BIA 2-093

ESL 1200 mg

ESL 1600 mg DRUG

two (2) tablets of 800 mg (QD).

Also known as: BIA 2-093

ESL 1600 mg

ESL 400 mg DRUG

half tablet of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL)

Also known as: BIA 2-093

ESL 400 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participated in the preceding double-blind study and were still ongoing at the time of unblinding.
• Have signed informed consent before undergoing any activities related to the open-label extension study.
• Demonstrated cooperation and willingness to complete all aspects of the study.
• 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).

You may not qualify if:

• Subjects having any of the following at Visit 1 are to be excluded from the study:
• 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.
• Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study.
• 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).
• 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.
• Events of alcohol, drug, or medication abuse during the preceding double-blind study.
• 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).
• Pregnancy or lactating.
• Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the extension-study protocol.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Related Publications (1)

• Trinka E, Rocamora R, Chaves J, Koepp MJ, Ruegg S, Holtkamp M, Moreira J, Fonseca MM, Castilla-Fernandez G, Ikedo F. Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study. Ther Adv Neurol Disord. 2023 Sep 4;16:17562864231193530. doi: 10.1177/17562864231193530. eCollection 2023.

  PMID: 37675038 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 29, 2015
• Study Start: March 1, 2016
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10