Epilepsy, PartialPhase 3NCT00175890
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
A Phase 3 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Pharma at 86 sites in 15 countries.
Trial summary
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 86 sitesin 15 countries
- Study dates
- Oct 2004to Jan 2007
- Phase
- Phase 3
- 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 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients from 1 month to less than 4 years of age
- Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening
- Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening
Who cannot join
- A ketogenic diet
- Previous exposure to levetiracetam
- Seizures too close together to count accurately
- Treatable seizure etiology
- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease
- Diagnosis of a terminal illness
Trial locations and contacts
86 sites in 15 countries.
86 sites in 15 countries
United States42 sites
Study site
Augusta, Georgia
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Chapel Hill, North Carolina
Study site
Cherry Hill, New Jersey
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Danville, Pennsylvania
Study site
Detroit, Michigan
Study site
Edison, New Jersey
Study site
Fort Worth, Texas
Study site
Gainesville, Florida
Study site
Hershey, Pennsylvania
Study site
Lebanon, New Hampshire
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Loxahatchee Groves, Florida
Study site
Miami, 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
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Saint Paul, Minnesota
Study site
Salt Lake City, Utah
Study site
Seattle, Washington
Study site
Spartanburg, South Carolina
Study site
Syracuse, New York
Study site
Tallahassee, Florida
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Winston-Salem, North Carolina
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
Canada6 sites
Study site
London, Ontario
Study site
Saskatoon, Saskatchewan
Study site
Scarborough Village, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Vancouver, British Columbia
Study site
Winnepeg, Manitoba
Germany6 sites
Study site
Berlin
Study site
Erlangen
Study site
Heidelberg
Study site
Jena
Study site
Kehl, Kork
Study site
Kiel
France4 sites
Study site
Lille
Study site
Paris
Study site
Rouen
Study site
Strasbourg
Italy4 sites
Study site
Calambrone
Study site
Genoa
Study site
Milan
Study site
Roma
Argentina3 sites
Study site
Buenos Aires
Study site
Mendoza
Study site
Pilar Buenos Aires
Romania3 sites
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Târgu Mureş
About this study
Official title: A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
- Conditions
- Epilepsy, Partial
- Being tested
- Levetiracetam, Placebo
- Keywords
- Partial Onset Seizure, levetiracetam, Video Electroencephalogram, Keppra
- 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
Also called Keppra
Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
PlaceboOther
Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days. Receives: Other: Placebo |
| Levetiractem | Experimental | 10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days. Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Secondary outcomes (10)
Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old
A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electroclinical seizures plus electrographic seizures.
Measured: 48-hours in Evaluation Period and 48-hours in Selection Period
Percentage of drop-outs for any reasons during the study
Measured: During the study (up to 20 days)
Percentage of drop-outs due to lack of efficacy during the study
Measured: During the study (up to 20 days)
Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy
Measured: During the study (up to 20 days)
Time to Exit (TTE) during the Evaluation Period
For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation - the day of randomization + 1. For completed subjects, the TTE was censored on Day 6.
Measured: During Evaluation Period (Day 1 to Day 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 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, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175890
- Sponsor's protocol ID
- N01009
- Other IDs
- 2004-000199-14, 2004
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2005
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Pina-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j.1528-1167.2008.01981.x. Epub 2009 Feb 21.
PubMed 19243423Pina-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 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age
- ClinicalTrials.gov ID
- NCT00175890
- Acronym / sponsor ID
- N01009
- Conditions
- Epilepsy, Partial
- Keywords
- Partial Onset Seizure, levetiracetam, Video Electroencephalogram, Keppra
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 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.
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMatching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days. |
| Levetiractem | Experimental | Drug: Levetiracetam10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days. |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients from 1 month to less than 4 years of age
- Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening
- Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening
Key exclusion criteria (6 listed)
- A ketogenic diet
- Previous exposure to levetiracetam
- Seizures too close together to count accurately
- Treatable seizure etiology
- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease
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 |
|---|---|---|
| LevetiracetamAlso: KeppraDosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d. | Drug | Levetiractem |
| PlaceboPlacebo solution, which is indistinguishable from the Levetiracetam oral solution. | Other | Placebo |
Primary outcome
Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.
10 secondary outcomes
Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percentage of drop-outs for any reasons during the study
Time frame: During the study (up to 20 days)
Percentage of drop-outs due to lack of efficacy during the study
Time frame: During the study (up to 20 days)
Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy
Time frame: During the study (up to 20 days)
Time to Exit (TTE) during the Evaluation Period
Time frame: During Evaluation Period (Day 1 to Day 6)
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 Oct 2020.
- Results publication: PubMed 19243423Pina-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j.1528-1167.2008.01981.x. Epub 2009 Feb 21.
- Derived from this study: 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.
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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
86 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Pharma at 86 sites in 15 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 3 inclusion and 6 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 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Brazil, Canada, Germany, France and 10 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. 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 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?
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?
Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) (time frame: 48-hours in Evaluation Period and 48-hours in Selection Period). 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 NCT00175890, which also lists 2 linked publications.
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 Oct 2020.