Epilepsy, PartialPhase 4NCT00245713
Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.
A Phase 4 study testing levetiracetam in people with Epilepsy, Partial, run by UCB Pharma.
Trial summary
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- levetiracetam
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Nov 2004
- Phase
- Phase 4
- 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 45 years
- All sexes
- Adult
Who may be able to join
- Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit
- Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment
Who cannot join
- Subjects dosing with LEV two weeks prior to the selection visit
- Subjects using more than one AED
- Subjects with specific and non-specific sleep disorders
About this study
Official title: 9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug
- Conditions
- Epilepsy, Partial
- Being tested
- levetiracetam
- Keywords
- Levetiracetam, adult, partial-onset epilepsy, antiepileptic
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
Secondary outcomes (1)
Secondary endpoints are based on the changes from Baseline to visit 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startMar 2003
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, PartialStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245713
- Sponsor's protocol ID
- N01085
- Status last verified
- Sep 2009
- First submitted
- 26 Oct 2005
- Last updated
- 26 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.
- ClinicalTrials.gov ID
- NCT00245713
- Acronym / sponsor ID
- N01085
- Conditions
- Epilepsy, Partial
- Keywords
- Levetiracetam, adult, partial-onset epilepsy, antiepileptic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 28 Oct 2005 (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.
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit
- Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment
Key exclusion criteria (3 listed)
- Subjects dosing with LEV two weeks prior to the selection visit
- Subjects using more than one AED
- Subjects with specific and non-specific sleep disorders
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 |
|---|---|---|
| levetiracetam | Drug | – |
Primary outcome
Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
1 secondary outcome
Secondary endpoints are based on the changes from Baseline to visit 7
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 26 Nov 2013.
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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
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levetiracetam in people with Epilepsy, Partial, run by UCB Pharma.
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 2 inclusion and 3 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.. 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 26 Nov 2013.