An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-06-30

Brief Summary

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The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Brivaracetam (ucb34714)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Well-characterized epileptic syndrome according to the ILAE classification.
* Patients currently treated with stable phenytoin monotherapy for at least three months and with at least one plasma measurement of pheyntoin within the target range (7 - 23 µg/ml) during the screening period.

Exclusion Criteria

* History of status epilepticus in the last year.
* Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been stable at least three months before entry into the study and will be kept stable for the entire trial duration.
* Subjects with a creatinine clearance of ≤50 mL/min.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No