EpilepsyPhase 1NCT00426673
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
A Phase 1 study testing Brivaracetam (ucb34714) in people with Epilepsy, run by UCB Pharma at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam (ucb34714)
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Jun 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Charlottesville, Virginia
Study site
Little Rock, Arkansas
Study site
Madison, Wisconsin
About this study
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
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.
- Conditions
- Epilepsy
- Being tested
- Brivaracetam (ucb34714)
- Keywords
- partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivaracetam (ucb34714)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startApr 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philipp von Rosenstiel, M.D., Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426673
- Sponsor's protocol ID
- N01172
- Status last verified
- Mar 2008
- First submitted
- 23 Jan 2007
- Last updated
- 10 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00426673
- Acronym / sponsor ID
- N01172
- Conditions
- Epilepsy
- Keywords
- partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 25 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brivaracetam (ucb34714) | Drug | – |
Primary outcome
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).
1 secondary outcome
information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp von Rosenstiel, M.D. study director
UCB Pharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brivaracetam (ucb34714) in people with Epilepsy, run by UCB Pharma at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2008.