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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00426673
• Date of registration: 23/01/2007
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
• Scientific 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
• Date of first enrolment: April 2005
• Target sample size: 15
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00426673
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Philipp von Rosenstiel, M.D.
• Affiliation: UCB Pharma

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Brivaracetam (ucb34714)

Primary Outcome(s)

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)

to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.

The drug interaction on phenytoin will be assessed by comparison of AUCt and Cmax between Visit 2 (phenytoin alone) and Visit 7 (combination of ucb 34714 and phenytoin).

Secondary Outcome(s)

information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.

Secondary ID(s)

N01172

Source(s) of Monetary Support

Please refer to primary and secondary sponsors