Nonconvulsive Electrographic SeizuresPhase 2NCT02088957
Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures
A Phase 2 study testing Brivaracetam intravenous solution, Brivaracetam oral tablets and Phenytoin intravenous solution in people with Nonconvulsive Electrographic Seizures, run by UCB BIOSCIENCES, Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nonconvulsive Electrographic Seizures
- What is being tested?
- Brivaracetam intravenous solution, Brivaracetam oral tablets and Phenytoin intravenous solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Oct 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects ≥16 years. Subjects under 18 years may only be included where legally permitted and ethically accepted
- Subjects in the neurological intensive care unit (NICU) (or equivalent closely monitored environment) having brain insult including traumatic brain injury and having nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG), lasting a minimum of 10 seconds but not >30 minutes (minimum of 1 seizure in the last 6 hours) and treatment with an antiepileptic drug (AED) is required according to the physician's clinical judgment
- Subject is expected to be under cEEG monitoring with video surveillance in the Neuro ICU for at least 36 hours from the first administration of study drug
Who cannot join
- Subject has history of severe adverse hematologic or cutaneous reaction to any drug
- Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE) (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting >30 minutes during Visit 1)
- Subject has been diagnosed with anoxic brain injury
- Subject has a known history of status epilepticus during the 6 months preceding Visit 1
- Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been treated within the last 30 days before Visit 1 with LEV or PHT
- Subject is on felbamate with <18 months' exposure before Visit 1
- Subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly progressing process such that the subject is not expected to survive >48 hours
- Subject has any clinical condition that would impair reliable participation in the study or necessitate the use of medications not allowed by the protocol
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Open-label, Multicenter, Parallel-group, Exploratory Study to Evaluate the Efficacy of Intravenous Brivaracetam and Intravenous Phenytoin in Subjects Experiencing Nonconvulsive Electrographic Seizures
The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.
- Conditions
- Nonconvulsive Electrographic Seizures
- Being tested
- Brivaracetam intravenous solution, Brivaracetam oral tablets, Phenytoin intravenous solution, Phenytoin oral tablets
- Keywords
- Brivaracetam, Phenytoin, Nonconvulsive electrographic seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivaracetam intravenous solutionDrug
- Active Substance: Brivaracetam
- Pharmaceutical Form: Solution for infusion
- Concentration: 10 mg/mL
- Route of Administration: Intravenous bolus use
Brivaracetam oral tabletsDrug
- Active Substance: Brivaracetam
- Pharmaceutical Form: Film-coated tablet
- Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid)
- Route of Administration: Oral use
Phenytoin intravenous solutionDrug
- Active Substance: Phenytoin
- Pharmaceutical Form: Solution for infusion
- Concentration: 50 mg/mL
- Route of Administration: Intravenous use
Phenytoin oral tabletsDrug
- Active Substance: Phenytoin
- Pharmaceutical Form: Tablet
- Concentration: Weight based
- Route of Administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets. Receives: Drug: Brivaracetam intravenous solution; Drug: Brivaracetam oral tablets |
| Phenytoin | Active comparator | Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.
Subjects should transition to oral medication as soon as they are able to swallow tablets. Receives: Drug: Phenytoin intravenous solution; Drug: Phenytoin oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Measured: From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Secondary outcomes (5)
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Measured: From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Measured: From start of first acute iv administration on Day 1
Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Measured: From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration
Measured: Between 15 minutes to 12 hours after first acute iv administration
Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration
Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
Measured: From start of first acute iv administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Termination of study due to low enrollment. There were no safety issues.
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 Nonconvulsive Electrographic SeizuresStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088957
- Sponsor's protocol ID
- N01394
- Status last verified
- Jul 2016
- First submitted
- 20 Feb 2014
- 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
- A Randomized, Open-label, Multicenter, Parallel-group, Exploratory Study to Evaluate the Efficacy of Intravenous Brivaracetam and Intravenous Phenytoin in Subjects Experiencing Nonconvulsive Electrographic Seizures
- ClinicalTrials.gov ID
- NCT02088957
- Acronym / sponsor ID
- N01394
- Conditions
- Nonconvulsive Electrographic Seizures
- Keywords
- Brivaracetam, Phenytoin, Nonconvulsive electrographic seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of study due to low enrollment. There were no safety issues.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 13 Apr 2016
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 study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam | Experimental | Drug: Brivaracetam intravenous solution, Drug: Brivaracetam oral tabletsSubjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months. Subjects should transition to oral medication as soon as they are able to swallow tablets. |
| Phenytoin | Active comparator | Drug: Phenytoin intravenous solution, Drug: Phenytoin oral tabletsSubjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months. Subjects should transition to oral medication as soon as they are able to swallow tablets. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects ≥16 years. Subjects under 18 years may only be included where legally permitted and ethically accepted
- Subjects in the neurological intensive care unit (NICU) (or equivalent closely monitored environment) having brain insult including traumatic brain injury and having nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG), lasting a minimum of 10 seconds but not >30 minutes (minimum of 1 seizure in the last 6 hours) and treatment with an antiepileptic drug (AED) is required according to the physician's clinical judgment
- Subject is expected to be under cEEG monitoring with video surveillance in the Neuro ICU for at least 36 hours from the first administration of study drug
Key exclusion criteria (8 listed)
- Subject has history of severe adverse hematologic or cutaneous reaction to any drug
- Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE) (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting >30 minutes during Visit 1)
- Subject has been diagnosed with anoxic brain injury
- Subject has a known history of status epilepticus during the 6 months preceding Visit 1
- Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been treated within the last 30 days before Visit 1 with LEV or PHT
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 intravenous solution* Active Substance: Brivaracetam * Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/mL * Route of Administration: Intravenous bolus use | Drug | Brivaracetam |
| Brivaracetam oral tablets* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid) * Route of Administration: Oral use | Drug | Brivaracetam |
| Phenytoin intravenous solution* Active Substance: Phenytoin * Pharmaceutical Form: Solution for infusion * Concentration: 50 mg/mL * Route of Administration: Intravenous use | Drug | Phenytoin |
| Phenytoin oral tablets* Active Substance: Phenytoin * Pharmaceutical Form: Tablet * Concentration: Weight based * Route of Administration: Oral use | Drug | Phenytoin |
Primary outcome
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing
Time frame: From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.
5 secondary outcomes
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing
Time frame: From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration
Time frame: From start of first acute iv administration on Day 1
Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing
Time frame: From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)
Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration
Time frame: Between 15 minutes to 12 hours after first acute iv administration
Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration
Time frame: From start of first acute iv administration
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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brivaracetam intravenous solution, Brivaracetam oral tablets and Phenytoin intravenous solution in people with Nonconvulsive Electrographic Seizures, run by UCB BIOSCIENCES, Inc. at 2 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 3 inclusion and 8 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: stopped early, 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 2 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 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 13 Apr 2016). 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?
Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing (time frame: From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)). 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.