EpilepsyPhase 2NCT03021018
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
A Phase 2 study testing Brivaracetam and Lorazepam in people with Epilepsy, run by UCB Biopharma S.P.R.L. at 14 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam and Lorazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 14 sitesUnited States
- Study dates
- 6 Feb 2017to 27 Apr 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female, 18 to 70 years of age, inclusive
- Subject has an established diagnosis of epilepsy
- Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening
Who cannot join
- Subject has previously participated in this study and was treated with study drug. Re-screen is permitted
- Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
- Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
- History or presence of status epilepticus during the 6 months prior to EMU admission
- Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
- Subject has > 2x upper limit of normal (ULN) of any of the following: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or > ULN total bilirubin
Show all 16Show fewer
- Subject has chronic liver disease
- Subject has hypersensitivity to BRV or any of its excipients
- Subject has a history of alcohol or drug abuse during the 6 months prior to EMU admission
- Subject with a history of psychogenic seizures
- Subject is a pregnant or lactating female
- Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in the opinion of the Investigator
- Subject has respiratory failure (or is at risk for respiratory failure), untreated sleep apnea, or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
- Subject has acute narrow-angle glaucoma or myasthenia gravis
- Subject is receiving benzodiazepine treatment (defined as an average of >=4 administrations per week) that started less than 28 days prior to EMU admission
- Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Ep0087 116
Belmont, Massachusetts, 02478
Ep0087 108
Birmingham, Alabama, 35294
Ep0087 106
Boston, Massachusetts, 02215
Ep0087 121
Chapel Hill, North Carolina, 27599
Ep0087 105
Charlotte, North Carolina, 28204
Ep0087 115
Chicago, Illinois, 60611
Ep0087 113
Chicago, Illinois, 60612
Ep0087 107
Detroit, Michigan, 48201
Ep0087 123
Hershey, Pennsylvania, 17033-2360
Ep0087 125
Lebanon, New Hampshire, 03756
Ep0087 112
Orlando, Florida, 32806
Ep0087 120
Rochester, New York, 14642
Ep0087 117
Tucson, Arizona, 85724
Ep0087 119
Wichita, Kansas, 67214
About this study
Official title: A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.
- Conditions
- Epilepsy
- Being tested
- Brivaracetam, Lorazepam
- Keywords
- Epilepsy, Brivaracetam, Epilepsy Monitoring Unit, Increased seizure activity
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Also called Briviact
- Pharmaceutical Form: Solution for infusion
- Concentration: 10 mg/ml
- Route of Administration: intravenous
LorazepamDrug
- Pharmaceutical Form: Solution for injection
- Route of Administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam (BRV) 100 mg | Experimental | Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period Receives: Drug: Brivaracetam |
| Brivaracetam (BRV) 200 mg | Experimental | Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period Receives: Drug: Brivaracetam |
| Lorazepam (LZP) | Active comparator | Lorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment. Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Measured: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Secondary outcomes (7)
Time to Next Seizure (Per Clinical Observation) or Rescue Medication
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Measured: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.
Measured: At 6 hours after the end of study drug administration
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
Measured: At 8 hours after the end of study drug administration
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
Measured: At 12 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.
Measured: During the 6 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
Measured: During the 8 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
Measured: During the 12 hours after the end of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start6 Feb 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, UCB (+1 844 599 2273)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021018
- Sponsor's protocol ID
- EP0087
- Status last verified
- Nov 2020
- First submitted
- 11 Jan 2017
- Last updated
- 16 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
- ClinicalTrials.gov ID
- NCT03021018
- Acronym / sponsor ID
- EP0087
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Brivaracetam, Epilepsy Monitoring Unit, Increased seizure activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 28 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam (BRV) 100 mg | Experimental | Drug: BrivaracetamTwo 5 ml vials of brivaracetam administered intravenously over a 2-minute period |
| Brivaracetam (BRV) 200 mg | Experimental | Drug: BrivaracetamFour 5 ml vials of brivaracetam administered intravenously over a 4-minute period |
| Lorazepam (LZP) | Active comparator | Drug: LorazepamLorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is male or female, 18 to 70 years of age, inclusive
- Subject has an established diagnosis of epilepsy
- Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening
Key exclusion criteria (16 listed)
- Subject has previously participated in this study and was treated with study drug. Re-screen is permitted
- Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
- Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
- History or presence of status epilepticus during the 6 months prior to EMU admission
- Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
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 |
|---|---|---|
| BrivaracetamAlso: Briviact* Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/ml * Route of Administration: intravenous | Drug | Brivaracetam (BRV) 100 mg, Brivaracetam (BRV) 200 mg |
| Lorazepam* Pharmaceutical Form: Solution for injection * Route of Administration: intravenous | Drug | Lorazepam (LZP) |
Primary outcome
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
Time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
7 secondary outcomes
Time to Next Seizure (Per Clinical Observation) or Rescue Medication
Time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
Time frame: At 6 hours after the end of study drug administration
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
Time frame: At 8 hours after the end of study drug administration
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
Time frame: At 12 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
Time frame: During the 6 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
Time frame: During the 8 hours after the end of study drug administration
Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
Time frame: During the 12 hours after the end of study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Product InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
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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.
UCB Cares study director
UCB (+1 844 599 2273)
14 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 and Lorazepam in people with Epilepsy, run by UCB Biopharma S.P.R.L. at 14 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 16 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 28 May 2019). 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?
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication (time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)). 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 16 Dec 2020.