Pharmacokinetics, Efficacy and Tolerability of BIA 2-093

NCT02170064 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-202
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.

Conditions

Epilepsy

Keywords

Epilepsy; BIA 2-093

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Drug Concentration (Cmax) Post-dose

  pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose

• Time of Occurrence of Cmax (Tmax).

  pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose

Secondary Outcomes (1)

• Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase

  Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).

Study Arms (3)

Group 1 (2-6 yrs)

EXPERIMENTAL

At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 1 (2-6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit.

Drug: BIA 2-093 (Eslicarbazepine acetate)

Group 2 (7-11 years)

EXPERIMENTAL

At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored).

Drug: BIA 2-093 (Eslicarbazepine acetate)

Group 3 (12-17 years)

EXPERIMENTAL

At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored).

Drug: BIA 2-093 (Eslicarbazepine acetate)

Interventions

BIA 2-093 (Eslicarbazepine acetate) DRUG

Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route

Group 1 (2-6 yrs); Group 2 (7-11 years); Group 3 (12-17 years)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient was eligible for entry into the baseline phase if he/she fulfilled the following criteria at Visit 1:
• Written informed consent given by the parent(s)/guardian(s), and by the patient when appropriate.
• Male or female patient aged between 2 and 17 years.
• Body weight within the 10th and 90th percentiles, by age and sex.
• A documented diagnosis of partial-onset seizures (simple or complex seizures with or without secondary generalisation), classified according to the International Classification of Epileptic Seizures.
• Currently treated with 1 to 3 AEDs (any except OXC or CBZ), in a stable dosage regimen during at least 1 month prior to screening.
• Good general health (apart from epilepsy) based on medical history and physical examination.
• In case of a female patient, she was premenarchal, surgically sterile or presented a urine pregnancy test consistent with a non-gravid state and practiced an effective non-hormonal contraception method.
• At Visit 2, patient was eligible for entry into the Eslicarbazepine acetate treatment phase if he/she fulfilled the following criteria:
• At least 4 partial-onset seizures during the last 4 weeks of the baseline phase.
• Brain CT scan or MRI that excluded rapidly progressive neurological diseases.
• ECG without clinically significant abnormalities.
• Good general health (apart from epilepsy) based on medical history, physical examination and laboratory tests at screening.
• Diaries satisfactorily completed by the patient or his/her caregiver during the baseline phase.
• Satisfactory compliance with the study requirements during the baseline phase.

You may not qualify if:

• Patient was not allowed for entry into the screening phase if he/she fulfilled the following criteria at Visit 1:
• Primarily generalised epilepsy.
• Clinically relevant medical condition, other than epilepsy.
• History of status epilepticus in the last 3 months.
• History of suicide attempt.
• History of alcohol or drug abuse.
• History of hypersensitivity or intolerance to OXC or CBZ.
• Use of any investigational drug or participated in any clinical trial within the previous 2 months.
• Patient and/or his/her caregiver(s) unlikely to co-operate with the requirements of the study.
• If female, she was sexually active and of child-bearing potential and she did not use reliable contraception.
• Patients with non-epileptic attacks (syncopes, pseudoseizures).
• Previous poor compliance with anti-epileptic therapy.
• Need for rescue benzodiazepines more frequently than twice per week on average.
• Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate.
• Any other condition or circumstance that, in the opinion of the investigator, might compromise the patient's ability to comply with the clinical trial protocol (CTP).

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Clinica de Neurologie Pediatrica, Spitalul "Alexandru Obregia"

Bucharest, 041914, Romania

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: BIAL - Portela & Cª, SA

clinical.trials@bial.com

+351-22 9866100

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: September 20, 2017
• Results First Posted: September 1, 2014

Record last verified: 2017-08

Locations

RO (1)