Back to resultsThe Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 1
Locations
Portugal
Study Type
Interventional
Intervention
Eslicarbazepine acetate
phenytoin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Anticonvulsant, BIA 2-093
Eligibility 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.
Sites / Locations
- Neurology Department, Hospital of Santa Maria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Eslicarbazepine acetate
phenytoin
Placebo
Arm Description
ESL 600 mg tablets
Hidantina® 100 mg tablets
Placebo tablets
Outcomes
Primary Outcome Measures
Number of Adverse Events reported
Number of the adverse events reported
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01878578
Brief Title
The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
prematurely terminated due to impossibility of recruiting the planned number of patients by the study centre.
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Anticonvulsant, BIA 2-093
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eslicarbazepine acetate
Arm Type
Experimental
Arm Description
ESL 600 mg tablets
Arm Title
phenytoin
Arm Type
Active Comparator
Arm Description
Hidantina® 100 mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate
Other Intervention Name(s)
BIA 2-093
Intervention Description
Tablets containing ESL 600 mg
Intervention Type
Drug
Intervention Name(s)
phenytoin
Other Intervention Name(s)
Hidantina® 100 mg tablets
Intervention Description
Hidantina® tablets containing 100 mg of phenytoin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablets
Intervention Description
Tablets containing matching placebo
Primary Outcome Measure Information:
Title
Number of Adverse Events reported
Description
Number of the adverse events reported
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Neurology Department, Hospital of Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients
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