Brief Summary

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

123

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2010

Geographic Reach

5 countries

36 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

August 1, 2010

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed

23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

October 24, 2014

Completed

Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.6 years

First QC Date

February 3, 2012

Results QC Date

January 10, 2014

Last Update Submit

October 23, 2014

Conditions

Partial Epilepsy

Keywords

Partial Epilepsyeslicarbazepine acetateChildren

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period
Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple \[dominant hand only\] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI's upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)
Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)

Secondary Outcomes (2)

Change From Baseline in Standardized Seizure Frequency - Part I
Baseline; Titration Period (4 Weeks: V2-V3-V4)
Change From Baseline in Seizure Frequency During the One-year Open-Label (OL)
Weeks 1 to ≥ 41 weeks

Study Arms (2)

Eslicarbazepine acetate (BIA 2-093)

EXPERIMENTAL

Drug: Eslicarbazepine acetate (BIA 2-093)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Eslicarbazepine acetate (BIA 2-093)DRUG

Eslicarbazepine acetate (ESL) tablets 200 mg and the matching placebo will be supplied. Treatments will be administered by oral route, once-daily, in the evening. The dose will be rounded to the nearest 100 mg unit. Half tablets may be used for dose adjustment if necessary.

Also known as: Eslicarbazepine acetate

Eslicarbazepine acetate (BIA 2-093)

PlaceboDRUG

Treatments will be administered by oral route, once-daily, in the evening.

Placebo

Eligibility Criteria

Age6 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

At visit 1 (screening), patient must be/have:
written informed consent by parent or legal guardian and, where applicable, the patient;
age 6 to 16 years, inclusive;
a documented diagnosis of epilepsy for at least 12 months prior to screening;
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;
an Intelligence Quotient (IQ) of at least 70;
current treatment with 1 to 2 AEDs (except oxcarbazepine, benzodiazepines other than clobazam and vagus nerve stimulation (VNS));
excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and clinical laboratory tests;
in the opinion of the investigator, able to complete the Cognitive Drug Research (CDR) test battery;
in case of a girl of childbearing potential, patient presents a serum B-human chorionic gonadotropin (B 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 post-study visit (PSV).
At visit 2 (randomisation), patient must be/have:
at least 2 partial-onset seizures during the 4 week baseline period prior to randomisation (documented in a diary);
in case of a girl of childbearing potential, patient presents a urine B-hCG test consistent with a non-gravid state;
stable dose regimen of concomitant AEDs during the 4 week baseline period;
diaries satisfactorily completed by the patient or his/her caregiver during the baseline period;
+1 more criteria

You may not qualify if:

At visit 1 (screening), patients must not be/have:
only simple partial seizures with no motor symptomatology;
primarily generalised seizures;
known rapidly progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion);
occurrence of seizures too close to count accurately;
history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening; seizures of non-epileptic origin;
Lennox-Gastaut syndrome;
West syndrome;
major psychiatric disorders;
seizures of psychogenic origin within the last 2 years;
history of schizophrenia or suicide attempt;
history of attention deficit disorder or other diseases adversely affecting cognitive abilities;
currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a routine or chronic basis) and/or VNS;
known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine);
uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder;
+10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bial - Portela C S.A.lead

Study Sites (36)

Ospedale Salesi

Ancona, 60123, Italy

Location

Ospedale Pediatrico Giovanni XXII

Bari, 70126, Italy

Location

Ospedale Maggiore "C.A. Pizzardi"

Bologna, 40133, Italy

Location

Istituto Scientifico G. Gaslini

Genova, 16146, Italy

Location

Ospedale Carlo Poma

Mantova, 46100, Italy

Location

Policlinico Martino

Messina, 98128, Italy

Location

Ospedale Fatebenefratelli

Milan, 20121, Italy

Location

Policlinico Seconda Università di Napoli

Napoli, 80131, Italy

Location

Istituto Mondino

Pavia, 27100, Italy

Location

Ospedale Bambin Gesu

Roma, 00165, Italy

Location

Azienda Ospedaliera O.I.R.M.- Sant'Anna

Torino, 10126, Italy

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Kempenhaeghe, location Heeze

Heeze, 5591 VE, Netherlands

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Gabinet Lekarski Neurologii Dzieciecej i Leczenia Padaczki

Kielce, 25-316, Poland

Location

Wielkopolskie Centrum Neurologii Dzieci i Mlodziezy

Poznan, 60-311, Poland

Location

AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego

Poznan, 60-355, Poland

Location

Instytut "Pomnik-Centrum Zdrowia Dziecka"

Warsaw, 04-730, Poland

Location

State Medical Institution "Children Republic Clinical Hospital of Minzdrav of Republic Tatarstan"

Kazan', 420138, Russia

Location

Moscow State Healthcare Institution Scientific and Practical centre of medical help to children

Moscow, 119620, Russia

Location

State Institution "Moscow Regional Scientific and Research Clinical Institute named after M.F. Vladimirsky"

Moscow, 129110, Russia

Location

OOO City Neurological Center "Sibneuromed"

Novosibirsk, 630091, Russia

Location

Saint Petersburg Scientific and Research Psycho-Neurology Institute

Saint Petersburg, 192019, Russia

Location

Saint-Petersburg State Pediatric Medical Academy of Ministry of Health and Social development of Russian Federation

Saint Petersburg, 194100, Russia

Location

Saint-Petersburg State Pediatric Medical Academy of Ministry of Health and Social

Saint Petersburg, 194100, Russia

Location

Institution Russian Academy of Science Institute of human brain RAN

Saint Petersburg, 197376, Russia

Location

Saint-Petersburg Sate Healthcare Institution "Children City Hospital #1"

Saint Petersburg, 198205, Russia

Location

State Healthcare Institution "Samarskaya Regional Clinical Hosptital named after M.I.Kalinin"

Samara, 443095, Russia

Location

Yaroslavskay State Medical Academy of Roszdrav

Yaroslavl, 150030, Russia

Location

Donetsk Region Child Clinical Centre of Neuroreabilitation

Donetsk, 83052, Ukraine

Location

Regional psycho-neurological hospital #3

Ivano-Frankivsk, 76014, Ukraine

Location

chair of neuropathology and pediatric neurology of Kharkov Medical Academy

Kharkiv, 61018, Ukraine

Location

Danylo Galytskyy Lviv National Medical University

Lviv, 79010, Ukraine

Location

Communal institution "Child City Hospital #3"

Odesa, 65125, Ukraine

Location

Vinnytsya National Medical University,Vinnytsya Regional Psychoneurological Hospital

Vinnitsa, 21005, Ukraine

Location

Zaporizhya regional clinical children hospital

Zaporizhzhya, 69063, Ukraine

Location

Related Publications (1)

Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Jozwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.
PMID: 31878820DERIVED

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title: Director R&D
Organization: BIAL - Portela & Cª SA

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 7, 2012

Study Start

August 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2013

Last Updated

October 24, 2014

Results First Posted

October 24, 2014

Record last verified: 2014-10

Locations

IT(11)PL(5)NL(2)RU(11)UA(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Eslicarbazepine acetate (BIA 2-093)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (36)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Study Design

Study Record Dates

Locations