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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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ClinicalTrials.gov Identifier: NCT00426673
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : March 10, 2008
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam (ucb34714) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2005
Primary Completion Date : June 2006
Study Completion Date : June 2006

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Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
  2. 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)
  3. 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 :
  1. information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharma
Investigators
Study Director: Philipp von Rosenstiel, M.D. UCB Pharma
More Information

ClinicalTrials.gov Identifier: NCT00426673     History of Changes
Other Study ID Numbers: N01172
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: March 10, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brivaracetam
Phenytoin
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers