An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
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|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)|
|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|
|Actual Primary Completion Date :||June 2006|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|