NCT01878578

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

June 12, 2013

Last Update Submit

February 26, 2014

Conditions

Epilepsy

Keywords

Anticonvulsant, BIA 2-093

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events reported

    Number of the adverse events reported

    3 weeks

Study Arms (3)

Eslicarbazepine acetate

EXPERIMENTAL

ESL 600 mg tablets

Drug: Eslicarbazepine acetate

phenytoin

ACTIVE COMPARATOR

Hidantina® 100 mg tablets

Drug: phenytoin

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

Interventions

Eslicarbazepine acetateDRUG

Tablets containing ESL 600 mg

Also known as: BIA 2-093
Eslicarbazepine acetate
phenytoinDRUG

Hidantina® tablets containing 100 mg of phenytoin

Also known as: Hidantina® 100 mg tablets
phenytoin
PlaceboDRUG

Tablets containing matching placebo

Also known as: Placebo tablets
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Department, Hospital of Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetatePhenytoin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 17, 2013

Study Start

November 1, 2002

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

PT(1)