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

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ClinicalTrials.gov Identifier: NCT01878578
Recruitment Status : Terminated (prematurely terminated due to impossibility of recruiting the planned number of patients by the study centre.)
First Posted : June 17, 2013
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Eslicarbazepine acetate Drug: phenytoin Drug: Placebo Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003


Arm Intervention/treatment
Experimental: Eslicarbazepine acetate
ESL 600 mg tablets
Drug: Eslicarbazepine acetate
Tablets containing ESL 600 mg
Other Name: BIA 2-093

Active Comparator: phenytoin
Hidantina® 100 mg tablets
Drug: phenytoin
Hidantina® tablets containing 100 mg of phenytoin
Other Name: Hidantina® 100 mg tablets

Placebo Comparator: Placebo
Placebo tablets
Drug: Placebo
Tablets containing matching placebo
Other Name: Placebo tablets




Primary Outcome Measures :
  1. Number of Adverse Events reported [ Time Frame: 3 weeks ]
    Number of the adverse events reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878578


Locations
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Portugal
Neurology Department, Hospital of Santa Maria
Lisbon, Portugal, 1649-035
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01878578     History of Changes
Other Study ID Numbers: BIA-2093-106
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by Bial - Portela C S.A.:
Anticonvulsant, BIA 2-093

Additional relevant MeSH terms:
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Eslicarbazepine acetate
Phenytoin
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers