An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
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
1 other identifier
interventional
15
1 country
3
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 administration on the steady-state plasma levels of phenytoin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 23, 2007
CompletedFirst Posted
Study publicly available on registry
January 25, 2007
CompletedMarch 10, 2008
March 1, 2008
1.2 years
January 23, 2007
March 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (3)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philipp von Rosenstiel, M.D.
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2007
First Posted
January 25, 2007
Study Start
April 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
March 10, 2008
Record last verified: 2008-03