A

Phase 1

• Conditions: Evaluate the effects of ESL oncognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures over a 12-week double blind period.; MedDRA version: 14.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2008-005606-39-PL
• Lead Sponsor: BIAL - Portela & Cª, SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-27
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

At Visit1 (screening), patient must be / have:
1.Written informed consent signed by parent or legal representative and, where applicable, the patient.
2.Aged 6 to 16 years, inclusive.
3.A documented diagnosis of epilepsy for at least 12 months prior to screening.
4.At least 2 partial onset seizures during the 4 weeks prior to screening despite treatment with 1 to 2 AEDs in a stable dose regimen.
5.An IQ of at least 70 within the 1 year prior to screening.
6.A parent or legal representative able to understand and willing to complete the CBCL and CHQ throughout the study.
7.Current treatment with 1 to 2 AEDs (any except oxcarbazepine).
8.Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
9.In the opinion of the investigator, able to complete the CDR test battery.
10.In case of a girl of childbearing potential, patient presents a serum ß-hCG test consistent with a non gravid state and agrees to remain abstinent or use reliable contraception (if used, hormonal contraception must be combined with a barrier method) starting at screening and continuing until at least the PSV.

At Visit 2 (randomisation), patient must have:
11.At least 2 partial-onset seizures during the 4-week baseline period prior to randomisation (documented in a diary).
12.In case of a girl of childbearing potential, patient presents a urine ß-hCG test consistent with a non-gravid state.
13.Stable dose regimen of concomitant AEDs during the 4 week baseline period.
14.Diaries satisfactorily completed by the patient or his/her caregiver during the baseline period.
15.Satisfactory compliance with the study requirements during the baseline period.
At OL7, the patient will be evaluated for eligibility into the Part III additional 2-year open-label extension. Assessments at this visit will be considered baseline values for Part III
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
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

At Visit1 (screening), patients must not be / have:
1. Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures).
2. Primarily generalised seizures.
3. Known rapidly progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
4. Occurrence of seizures too close together to count accurately.
5. History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
6. Seizures of non-epileptic origin.
7. Lennox-Gastaut syndrome.
8. West syndrome.
9. Major psychiatric disorders.
10. Seizures of psychogenic origin within the last 2 years.
11. History of schizophrenia or suicide attempt.
12. Documented and established diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD) currently treated with stimulants or history of other diseases adversely affecting cognitive abilities (if stable ADHD and not treated with stimulants patients can be included).
13. Currently treated with oxcarbazepine.
14. Occasional use of benzodiazepines for any reason other than epilepsy.
15. On ketogenic diet.
16. Receiving VNS
17. Known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine).
18. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
19. Second or third degree atrioventricular blockade.
20. Relevant clinical laboratory abnormalities.
21. Estimated creatinine clearance (CLCR) <60 mL/min.
22. Pregnancy or nursing.
23. Treatment with ESL in any previous study.
24. Participation in other drug clinical trial within the last 2 months.
25. Not ensured capability to perform the trial.
26. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.

At Visit 2 (randomisation), patients must not be / have:
27.Any condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.

Study & Design

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