An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Brivaracetam (ucb34714) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Philipp von Rosenstiel, M.D., Study Director, Affiliation: UCB
Summary
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: 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 outcome: information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Little Rock, Arkansas, United States
Charlottesville, Virginia, United States
Madison, Wisconsin, United States
Additional Information
Starting date: April 2005
Ending date: June 2006
Last updated: March 7, 2008
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