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

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00426673

Purpose

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
Epilepsy	Drug: Brivaracetam (ucb34714)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Phenytoin Brivaracetam Phenytoin sodium

U.S. FDA Resources

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)

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426673

Locations

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.

Investigators

Study Director:

Philipp von Rosenstiel, M.D.

UCB, Inc.

More Information

No publications provided

Study ID Numbers:	N01172
Study First Received:	January 23, 2007
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00426673 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

partial onset seizures, phenytoin, dilatin, brivaracetam, interaction

Additional relevant MeSH terms:

Phenytoin
Epilepsy
Therapeutic Uses
Nervous System Diseases
Central Nervous System Diseases

Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on November 09, 2009