Official Title: “A Multi-Center, Open-Label, Unilateral Interaction Study of Ucb 34714 on Stable Phenytoin Monotherapy During a 45 Day b.i.d. Administration Period in 15 Adult Subjects Suffering From Epilepsy”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: June 2006

Intervention(s) in this Clinical Trial

• Drug: Brivaracetam (ucb34714)

Primary Measures

• to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
• Blood samples for PK calculations collected at different time points, on Visit 2 and Visit 7, for determination of phenytoin plasma concentrations (Phenytoin levels at pre-dose, 1, 2, 4, 6, 8, 12 (24 if PHT od) hours at V2 and V7)
• The drug interaction on phenytoin will be assessed by comparison of AUCτ and Cmax between Visit 2 (phenytoin alone) and Visit 7 (combination of ucb 34714 and phenytoin).

Secondary Measures

• information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Philipp von Rosenstiel, M.D. Study Director UCB  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426673

Study ID Number: N01172

ClinicalTrials.gov Identifier: NCT00426673

Health Authority: United States: Food and Drug Administration