EpilepsyPhase 2NCT00422422
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
A Phase 2 study testing Brivaracetam in people with Epilepsy, run by UCB Pharma at 39 sites in 6 countries.
Trial summary
Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 39 sitesin 6 countries
- Study dates
- Jul 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of epilepsy
- Subject having at least 1 seizure (any type) during the 3 weeks before first visit
- Stable dosing of 1-3 concomitant antiepileptic drugs
Who cannot join
- Pregnant or nursing females
- Concomitant use of Levetiracetam
- Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
- History of status epilepticus
- Clinically significant acute or chronic illness, underlying disease or medication condition
- History of suicide attempt
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
United States12 sites
106
Boston, Massachusetts
105
Buffalo, New York
113
Chesterfield, Missouri
107
Cincinnati, Ohio
108
Gulf Breeze, Florida
117
Houston, Texas
110
Miami, Florida
109
Nashville, Tennessee
114
Pittsburgh, Pennsylvania
104
Rochester, New York
101
Saint Paul, Minnesota
103
Wellington, Florida
Poland8 sites
404
Bialystok
403
Gdansk
406
Kielce
402
Krakow
401
Poznan
408
Rzeszów
407
Szczecin
405
Wroclaw
Mexico7 sites
602
Aguascalientes
611
Chihuahua City
609
Ciuliacan
603
Guadalajara
604
Mexico City
610
Monterrey
607
San Luis Potosí City
Spain6 sites
309
Barcelona
306
Madrid
301
Palma de Mallorca
304
Santander
308
Valencia
303
Zaragoza
About this study
Official title: Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy
Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.
- Conditions
- Epilepsy
- Being tested
- Brivaracetam
- Keywords
- Brivaracetam, Epilepsy, Child, Pharmacokinetics, Adolescents
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Oral solution
Evaluation period (3 weeks up-titration):
For subjects ≥8 years:
- ~0.4 mg/kg bid for Week 1
- ~0.8 mg/kg bid for Week 2
- ~1.6 mg/kg bid for Week 3
For subjects <8 years:
- ~0.5 mg/kg bid for Week 1
- ~1.0 mg/kg bid for Week 2
- ~2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
- ~0.8 mg/kg bid for Week 4
- ~0.4 mg/kg bid for Week 5
For subjects <8 years:
- ~1.0 mg/kg bid for Week 4
- ~0.5 mg/kg bid for Week 5
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | Not described Receives: Drug: Brivaracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
Measured: Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
Measured: Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Measured: Day 21
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Measured: Day 21
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Measured: Day 21
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
Measured: Day 21
Secondary outcomes (3)
Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period
Measured: Baseline to end of the 3-week evaluation period
Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period
Measured: Baseline to end of the 3-week evaluation period
Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period
Measured: Baseline to the end of the 3-week evaluation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422422
- Sponsor's protocol ID
- N01263
- Other IDs
- 2006-006536-22
- Status last verified
- Nov 2016
- First submitted
- 10 Jan 2007
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy
- ClinicalTrials.gov ID
- NCT00422422
- Acronym / sponsor ID
- N01263
- Conditions
- Epilepsy
- Keywords
- Brivaracetam, Epilepsy, Child, Pharmacokinetics, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jan 2007 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam | Experimental | Drug: Brivaracetam |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of epilepsy
- Subject having at least 1 seizure (any type) during the 3 weeks before first visit
- Stable dosing of 1-3 concomitant antiepileptic drugs
Key exclusion criteria (6 listed)
- Pregnant or nursing females
- Concomitant use of Levetiracetam
- Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
- History of status epilepticus
- Clinically significant acute or chronic illness, underlying disease or medication condition
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 |
|---|---|---|
| BrivaracetamOral solution Evaluation period (3 weeks up-titration): For subjects ≥8 years: * ~0.4 mg/kg bid for Week 1 * ~0.8 mg/kg bid for Week 2 * ~1.6 mg/kg bid for Week 3 For subjects <8 years: * ~0.5 mg/kg bid for Week 1 * ~1.0 mg/kg bid for Week 2 * ~2.0 mg/kg bid for Week 3 Down-titration period (up to 2 weeks): For subjects ≥8 years: * ~0.8 mg/kg bid for Week 4 * ~0.4 mg/kg bid for Week 5 For subjects <8 years: * ~1.0 mg/kg bid for Week 4 * ~0.5 mg/kg bid for Week 5 | Drug | Brivaracetam |
Primary outcome
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
Time frame: Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
Time frame: Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Time frame: Day 21
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Time frame: Day 21
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Time frame: Day 21
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
Time frame: Day 21
3 secondary outcomes
Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period
Time frame: Baseline to end of the 3-week evaluation period
Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period
Time frame: Baseline to end of the 3-week evaluation period
Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period
Time frame: Baseline to the end of the 3-week evaluation period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brivaracetam in people with Epilepsy, run by UCB Pharma at 39 sites in 6 countries.
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 3 inclusion and 6 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Poland, Mexico, Spain, Belgium and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years (time frame: Day 21). The study lists 6 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 11 Jul 2018.