The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

Epilepsy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01878578
• Other study ID #: BIA-2093-106
• Status: Terminated
• Phase: Phase 1
• First received: June 12, 2013
• Last updated: February 26, 2014
• Start date: November 2002
• Est. completion date: March 2003

Study information

• Verified date: February 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA 2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the tolerability and safety of ESL administered concomitantly with phenytoin in patients.

Description:

This study was planned as a single-dose, open label phase (Phase A) followed by a multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover phase (Phase B) study in patients taking phenytoin. Phase B consisted of two 14-day treatment periods separated by a washout period of 10 to 15 days. Subjects continued their usual phenytoin scheme and received a single dose of ESL 1200 mg (Phase A) and either ESL (600 mg from Day 1 to 7 and 1200 mg from Day 8 to 14) or matching placebo once-daily for 14 days in each period.

The study was prematurely terminated due to impossibility of recruiting the planned number of patients. Only 4 patients were admitted and this was considered a too small sample size to allow a reliable assessment of the potential interaction between ESL and phenytoin. Therefore, no pharmacokinetic evaluation was performed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female subjects aged between 18 and 65 years, inclusive.

• Subjects who were on an established regimen of phenytoin monotherapy, which had been stable for at least 3 months.

• Subjects who had clinical laboratory tests acceptable to the Investigator.

• Subjects who were negative for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab) and human immunodeficiency viruses (HIV-1 and HIV-2) Ab tests at screening.

• Subjects who were negative for alcohol and drugs of abuse at screening.

• Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.

• Subjects who were able and willing to gave written informed consent.

• (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.

• (If female) She had a negative pregnancy test at screening.

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria.

• Subjects who had a clinically relevant history or presence of any disease that may interfere with the pharmacokinetics or pharmacodynamics of the Investigational Products, or may affect its safety.

• Subjects who had a history of relevant drug hypersensitivity.

• Subjects who had a history of alcoholism or drug abuse in the last 2 years.

• Subjects who consumed more than 21 units of alcohol a week.

• Subjects who had one of the following findings on the electrocardiogram (ECG): sinus bradycardia, sinoatrial block, atrioventricular block of any degree.

• Subjects who had a significant infection or known inflammatory process on screening and/or admission.

• Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).

• Subjects who had used any drugs (other than phenytoin) that may affect the pharmacokinetic profile of the investigational products within 2 weeks of first dosing.

• Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.

• Subjects who had previously received ESL.

• Subjects who had donated and/or received any blood or blood products within the previous 3 months prior to screening.

• Subjects who were vegetarians, vegans and/or have medical dietary restrictions.

• Subjects who cannot communicate reliably with the investigator.

• Subjects who were unlikely to co-operate with the requirements of the study.

• Subjects who were unwilling or unable to gave written informed consent.

• (If female) She was pregnant or breast-feeding.

• (If female) She was of childbearing potential and she did not use an approved effective contraceptive method.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Eslicarbazepine acetate
Tablets containing ESL 600 mg
• phenytoin
Hidantina® tablets containing 100 mg of phenytoin
• Placebo
Tablets containing matching placebo

Locations

Country	Name	City	State
Portugal	Neurology Department, Hospital of Santa Maria	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events reported	Number of the adverse events reported	3 weeks	Yes