Clinical Trial to investigate the safety and tolerability ofEslicarbazepine Acetate as additive therapy in babies aged from 1 month to <2 years with refractory epilepsy with partial-onset seizures for one year

Phase 1

• Conditions: refractory epilepsy with partial-onset seizures in children aged from 1month to < 2 years; MedDRA version: 21.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001072-29-PT
• Lead Sponsor: BIAL - Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-21
• Study Completion: 2021-05-11
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

- Have an informed consent signed by their parent(s) or guardian(s) before undergoing any study-related activities.
- Current treatment with 1 to 2 anti-epileptic drugs (except oxcarbazepine; vagus nerve stimulation if present and functioning will not be counted as an anti-epileptic drug).
- Have completed the Evaluation Period in Study 211.

Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Diagnosis of treatable seizure aetiology such as metabolic, toxic, and infectious disorders.
- Primarily generalised seizures.
- Known rapidly progressive neurological disorders (e.g. rapidly progressive brain disease, epilepsy secondary to rapidly progressive cerebral lesion).
- Seizures of non-epileptic origin.
- Diagnosis with Epileptiform Encephalopathies (Early Myoclonic Encephalopathy, Ohtahara syndrome, West syndrome [current], Dravet’s syndrome, or Lennox-Gastaut syndrome).
- Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorders.
- Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine), or to any of the excipients, in particular methyl parahydroxybenzoate (E218) or sulphites.
- Relevant clinical laboratory abnormalities (e.g. sodium <130 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (measured at Visit 1).
- Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.

Study & Design

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