An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.

This study has been completed.
Information provided by:
UCB, Inc. Identifier:
First received: January 23, 2007
Last updated: March 7, 2008
Last verified: March 2008

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.

Condition Intervention Phase
Drug: Brivaracetam (ucb34714)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by UCB, Inc.:

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.

Estimated Enrollment: 15
Study Start Date: April 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00426673

United States, Arkansas
Little Rock, Arkansas, United States
United States, Virginia
Charlottesville, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
UCB, Inc.
Study Director: Philipp von Rosenstiel, M.D. UCB, Inc.
  More Information

No publications provided Identifier: NCT00426673     History of Changes
Other Study ID Numbers: N01172
Study First Received: January 23, 2007
Last Updated: March 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
partial onset seizures, phenytoin, dilatin, brivaracetam, interaction

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 15, 2014