An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
|ClinicalTrials.gov Identifier: NCT00426673|
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : March 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Brivaracetam (ucb34714)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2005|
|Primary Completion Date :||June 2006|
|Study Completion Date :||June 2006|
- 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).
- information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426673
|United States, Arkansas|
|Little Rock, Arkansas, United States|
|United States, Virginia|
|Charlottesville, Virginia, United States|
|United States, Wisconsin|
|Madison, Wisconsin, United States|
|Study Director:||Philipp von Rosenstiel, M.D.||UCB Pharma|