Back to resultsAn Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brivaracetam (ucb34714)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
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 Measures
information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00426673
Brief Title
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Brivaracetam (ucb34714)
Primary Outcome Measure Information:
Title
to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
Title
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)
Title
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 Measure Information:
Title
information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp von Rosenstiel, M.D.
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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