EpilepsyPhase 1NCT00736931
Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
A Phase 1 study testing Brivaracetam, levetiracetam and lorazepam in people with Epilepsy, run by UCB Pharma at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam, levetiracetam and lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2008
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteer aged 18 to 50 years inclusive
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive
- Good physical and mental health status
- Blood pressure and heart rate within normal range
- Electrocardiogram and laboratory tests without clinically significant abnormality
Who cannot join
- IQ ≤ 80 as determined by Test of non-verbal intelligence
- Center for Epidemiological Studies Depression (CES-D Scale ≥16,
- Known allergy/intolerance to pyrrolidinone derivatives
- Abnormalities on EEG recordings
- Pregnant, lactating women
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders
- Use of any hepatic enzyme-inducing drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects
The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
- Conditions
- Epilepsy
- Being tested
- Brivaracetam, levetiracetam, lorazepam, placebo
- Keywords
- Brivaracetam, Cognitive neurophysiological tests (CNT), Neuropsychological assessments
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Brivaracetam 10 mg tablets
levetiracetamDrug
500mg tablets
lorazepamDrug
lorazepam 2 mg over encapsulated tablets
placeboOther
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Receives: Drug: Brivaracetam |
| 2 | Active comparator | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Receives: Drug: levetiracetam |
| 3 | Active comparator | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Receives: Drug: lorazepam |
| 4 | Placebo comparator | 4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)
Measured: 3 weeks
Secondary outcomes (1)
Component subscores from the Cognitive Neurophysiological Test and scores from neuropsychological tests/assessments: SSEQ Subject Self Evaluation Questionnaire. SMDT Symbol Digit Modalities Test. COWA Controlled Oral Word Association. MCG Parag
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT00736931
- Sponsor's protocol ID
- N01297
- Status last verified
- Oct 2008
- First submitted
- 14 Aug 2008
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Meador KJ, Gevins A, Leese PT, Otoul C, Loring DW. Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam. Epilepsia. 2011 Feb;52(2):264-72. doi: 10.1111/j.1528-1167.2010.02746.x. Epub 2010 Sep 30.
PubMed 20887370
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00736931
- Acronym / sponsor ID
- N01297
- Conditions
- Epilepsy
- Keywords
- Brivaracetam, Cognitive neurophysiological tests (CNT), Neuropsychological assessments
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Aug 2008 (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 the study is to evaluate the neurocognitive effects of brivaracetam
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Brivaracetam4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
| 2 | Active comparator | Drug: levetiracetam4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
| 3 | Active comparator | Drug: lorazepam4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
| 4 | Placebo comparator | Other: placebo4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female volunteer aged 18 to 50 years inclusive
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive
- Good physical and mental health status
- Blood pressure and heart rate within normal range
- Electrocardiogram and laboratory tests without clinically significant abnormality
Key exclusion criteria (7 listed)
- IQ ≤ 80 as determined by Test of non-verbal intelligence
- Center for Epidemiological Studies Depression (CES-D Scale ≥16,
- Known allergy/intolerance to pyrrolidinone derivatives
- Abnormalities on EEG recordings
- Pregnant, lactating women
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 |
|---|---|---|
| BrivaracetamBrivaracetam 10 mg tablets | Drug | 1 |
| levetiracetam500mg tablets | Drug | 2 |
| lorazepamlorazepam 2 mg over encapsulated tablets | Drug | 3 |
| placeboplacebo capsules | Other | 4 |
Primary outcome
Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)
Time frame: 3 weeks
1 secondary outcome
Component subscores from the Cognitive Neurophysiological Test and scores from neuropsychological tests/assessments: SSEQ Subject Self Evaluation Questionnaire. SMDT Symbol Digit Modalities Test. COWA Controlled Oral Word Association. MCG Parag
Time frame: 3 weeks
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 28 May 2012.
- Derived from this study: PubMed 20887370Meador KJ, Gevins A, Leese PT, Otoul C, Loring DW. Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam. Epilepsia. 2011 Feb;52(2):264-72. doi: 10.1111/j.1528-1167.2010.02746.x. Epub 2010 Sep 30.
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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 Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
1 site 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, levetiracetam and lorazepam in people with Epilepsy, run by UCB Pharma at 1 site 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 5 inclusion and 7 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 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736931, which also lists 1 linked publication.
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 28 May 2012.