EpilepsyPhase 2NCT00401648
Effect of Brivaracetam in Photosensitive Epileptic Subjects
A Phase 2 study testing Brivaracetam in people with Epilepsy, run by UCB Pharma at 5 sites in 2 countries.
Trial summary
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2002to Jun 2003
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- epileptic subjects with generalized PPR
Who cannot join
- more than 2 concomitant antiepileptic drugs
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Study site
Marseille
Study site
Paris
Study site
Rouen
Study site
Strasbourg
About this study
Official title: A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects
- Conditions
- Epilepsy
- Being tested
- Brivaracetam
- Keywords
- POC, photosensitive, epileptic, brivaracetam, PPR, AED
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
post placebo during 24h and post brivaracetam for up to 72 h
Secondary outcomes (2)
Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startSep 2002
- Primary completionJun 2003
- Study completionJun 2003
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philipp von Rosenstiel, MD., Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401648
- Sponsor's protocol ID
- N01069
- Other IDs
- Protocol Number RPCE02D2304
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2006
- Last updated
- 1 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.
- ClinicalTrials.gov ID
- NCT00401648
- Acronym / sponsor ID
- N01069
- Conditions
- Epilepsy
- Keywords
- POC, photosensitive, epileptic, brivaracetam, PPR, AED
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 20 Nov 2006 (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.
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- epileptic subjects with generalized PPR
Key exclusion criteria (1 listed)
- more than 2 concomitant antiepileptic drugs
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 | Drug | – |
Primary outcome
Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
post placebo during 24h and post brivaracetam for up to 72 h
2 secondary outcomes
Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
Safety
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 1 Dec 2009.
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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, MD. study director
UCB Pharma
5 sites in 2 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 5 sites in 2 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 1 inclusion and 1 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 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany. 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?
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?
Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose. The study lists 2 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 1 Dec 2009.