Clinical Trial to investigate the bioavailability, safety and tolerability of Eslicarbazepine Acetate as additive therapy in babies aged from 1 month to <2 years with refractory epilepsy with partial-onset seizures

Phase 1

• Conditions: refractory epilepsy with partial-onset seizures in children aged from 1 month 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: EUCTR2012-001091-11-PT
• 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: 2017-03-21
• Study Completion: 2020-04-03
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Have an informed consent signed by their parent(s) or guardian(s) before undergoing any study-related activities.
2. Male or female =1 month (i.e. at least 28 days) but <2 years of age.
3. Weigh a minimum of 4 kg at Visit 1.
4. Epilepsy refractory to treatment with 1 to 2 AEDs and with clinical or electroencephalogram (EEG) evidence of partial onset seizures for at least 1 month in infants =6 months of age, or for at least 2 weeks in infants <6 months of age, as defined by the International League Against Epilepsy. In case a child has a significant birth defect, hydrocephalus, or tetraparesis, EEG confirmation must be available.
5. Current treatment with 1 to 2 AEDs (except OXC; vagus nerve stimulation if present and functioning will not be counted as an AED).
6. Ability to come to the study site every day during the Titration/Evaluation Periods.

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

1. A neonate who is a preterm baby (i.e. born before 36 weeks of gestation).
2. Diagnosis of treatable seizure aetiology such as metabolic, toxic, and infectious disorders.
3. Primarily generalised seizures.
4. Known rapidly progressive neurological disorders (e.g. rapidly progressive brain disease, epilepsy secondary to rapidly progressive cerebral lesion).
5. History of status epilepticus or cluster seizures (i.e. 3 or more seizures within 30 minutes) within the month prior to screening.
6. Seizures of non-epileptic origin.
Ohtahara syndrome, West syndrome [current], Dravet’s syndrome, or Lennox-Gastaut syndrome).
8. Difficult venous access.
9. Ketogenic diet.
10. Currently treated with OXC (at Screening or for at least 2 weeks before).
11. Previous use of ESL.
12. An AED that started or was discontinued in the 3 weeks before Visit 1.
13. Diseases that can have an impact on drug absorption (e.g. any disease leading to diarrhoea or vomiting).
14. Treatments that can have an impact on blood volume (e.g. transfusions or intravenous infusions).
15. Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, OXC), or to any of the excipients, in particular methyl parahydroxybenzoate (E218) or sulphites.
16. Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorders.
17. 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).
18. Estimated glomerular filtration rate below the lower limit of the normal range (measured at Visit 1).
19. Participation in other drug clinical trial within the last 2 months or having received an IMP within 5 half-lives of that IMP, whichever is longer.
20. 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