Epilepsy, PartialPhase 3NCT00152516
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
A Phase 3 study testing levetiracetam (LEV) in people with Epilepsy, Partial, run by UCB Pharma at 84 sites in 16 countries.
Trial summary
To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- levetiracetam (LEV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 84 sitesin 16 countries
- Study dates
- Oct 2004to Jun 2008
- Phase
- Phase 3
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit
Who cannot join
- Patients on a ketogenic diet
- Seizures too close together to accurately count
- Pseudoseizures
- Status epilepticus 1 month prior Visit 1
- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.
Trial locations and contacts
84 sites in 16 countries.
84 sites in 16 countries
United States38 sites
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Boston, Massachusetts
Study site
Bradenton, Florida
Study site
Buffalo, New York
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Denver, Colorado
Study site
Edison, New Jersey
Study site
Fort Worth, Texas
Study site
Galveston, Texas
Study site
Germantown, Tennessee
Study site
Hershey, Pennsylvania
Study site
Lebanon, New Hampshire
Study site
Los Angeles, California
Study site
Loxahatchee Groves, Florida
Study site
Milwaukee, Wisconsin
Study site
Mobile, Alabama
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Pensacola, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Saint Paul, Minnesota
Study site
Salt Lake City, Utah
Study site
Syracuse, New York
Study site
Tallahassee, Florida
Study site
Tampa, Florida
Study site
Voorhees Township, New Jersey
Study site
Washington D.C., District of Columbia
Brazil6 sites
Study site
Campinas
Study site
Curitiba
Study site
Porto Alegre
Study site
Ribeirão Preto
Study site
Rio de Janeiro
Study site
São Paulo
Germany6 sites
Study site
Berlin
Study site
Erlangen
Study site
Heidelberg
Study site
Jena
Study site
Kehl, Kork
Study site
Kiel
India5 sites
Study site
Hyderabad
Study site
Lucknow
Study site
Mahim Mumbai
Study site
Mumbai
Study site
Pune Maharashtra
Italy4 sites
Study site
Calambrone
Study site
Genoa
Study site
Milan
Study site
Roma
Canada3 sites
Study site
Thornhill, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Romania3 sites
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Târgu Mureş
South Africa3 sites
Study site
Cape Town
Study site
Capitol Park
Study site
Johannesburg
United Kingdom3 sites
Study site
Bristol
Study site
Cardiff
Study site
London
About this study
Official title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.
To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.
- Conditions
- Epilepsy, Partial
- Being tested
- levetiracetam (LEV)
- Keywords
- Partial Onset Seizures, levetiracetam, Epilepsy, Keppra
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetam (LEV)Drug
Also called Keppra
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Not described Receives: Drug: levetiracetam (LEV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Measured: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Secondary outcomes (20)
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Measured: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Measured: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Measured: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Measured: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Measured: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.
Note: Rates were reported as percentages.
Measured: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Measured: Subjects with up to 24 weeks of exposure
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Measured: Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Measured: Subjects with up to 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Measured: Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.
The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks.
Measured: greater than or equal to 24 weeks, greater than or equal to 40 weeks
Percent of Subjects With Each Seizure Type During the Evaluation Period
Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).
Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).
Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).
A subject could experience more than one seizure type.
Measured: Evaluation period (48 weeks)
Investigator Global Evaluation Scale
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
Measured: End of Evaluation period (week 48 or at point of early discontinuation)
Parent/Guardian Global Evaluation Scale
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
Measured: End of Evaluation period (week 48 or at point of early discontinuation)
Subject (>=8 Years Old) Global Evaluation Scale
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
Measured: End of Evaluation period (week 48 or at point of early discontinuation)
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.
Measured: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Measured: Visit 5 (Week 24)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Measured: Visit 7 (week 48)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Measured: Visit 5 (week 24)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Measured: Visit 7 (week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJun 2008
- Study completionJun 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152516
- Sponsor's protocol ID
- N01148
- Other IDs
- EudraCT number:2004-000200-40
- Status last verified
- Apr 2010
- First submitted
- 7 Sep 2005
- Last updated
- 12 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.
PubMed 21095488
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.
- ClinicalTrials.gov ID
- NCT00152516
- Acronym / sponsor ID
- N01148
- Conditions
- Epilepsy, Partial
- Keywords
- Partial Onset Seizures, levetiracetam, Epilepsy, Keppra
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Posted 13 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: levetiracetam (LEV) |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit
Key exclusion criteria (5 listed)
- Patients on a ketogenic diet
- Seizures too close together to accurately count
- Pseudoseizures
- Status epilepticus 1 month prior Visit 1
- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the 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 |
|---|---|---|
| levetiracetam (LEV)Also: KeppraPer protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period. | Drug | Levetiracetam |
Primary outcome
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
20 secondary outcomes
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Time frame: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time frame: Subjects with up to 24 weeks of exposure
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time frame: Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time frame: Subjects with up to 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time frame: Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
Time frame: greater than or equal to 24 weeks, greater than or equal to 40 weeks
Percent of Subjects With Each Seizure Type During the Evaluation Period
Time frame: Evaluation period (48 weeks)
Investigator Global Evaluation Scale
Time frame: End of Evaluation period (week 48 or at point of early discontinuation)
Parent/Guardian Global Evaluation Scale
Time frame: End of Evaluation period (week 48 or at point of early discontinuation)
Subject (>=8 Years Old) Global Evaluation Scale
Time frame: End of Evaluation period (week 48 or at point of early discontinuation)
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
Time frame: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
Time frame: Visit 5 (Week 24)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
Time frame: Visit 7 (week 48)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
Time frame: Visit 5 (week 24)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
Time frame: Visit 7 (week 48)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21095488Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
84 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levetiracetam (LEV) in people with Epilepsy, Partial, run by UCB Pharma at 84 sites in 16 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 5 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 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Brazil, Germany, India, Italy and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jan 2010). 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 Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. (time frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 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 NCT00152516, 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 12 Feb 2013.