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

Completed · Phase 1

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00426673

Run by

UCB Pharma

People needed

15

Starts

2005-04-01

Expected to finish

2006-06-01

Last updated by the study team

2008-03-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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