Status:
COMPLETED
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 administ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00426673
Start Date
April 1 2005
End Date
June 1 2006
Last Update
March 10 2008
Active Locations (3)
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1
Little Rock, Arkansas, United States
2
Charlottesville, Virginia, United States
3
Madison, Wisconsin, United States