EpilepsyPhase 3NCT00615615

Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

A Phase 3 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures. Read more about this study

Who is it for?: Ages 4 to 16 years
Conditions the study is for: Epilepsy
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: 216 participants
Where: No sites listed yet
Study dates: Sep 1999to Mar 2003
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 4 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit
epilepsy was classifiable according to the ILAE Classification
>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
unsatisfactory current AED treatment in terms of efficacy and/or safety
stable AED treatment consisting of no more than two AEDs

Who cannot join

treatable seizure etiology
epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
history of or the presence of pseudo seizures
current diagnosis of Lennox-Gastaut syndrome

About this study

Official title: Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.

Conditions: Epilepsy
Being tested: Levetiracetam, Placebo
Keywords: Levetiracetam, Keppra
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevetiracetamDrug
- high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
- low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less
PlaceboDrug
Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Study groups in NCT00615615
Study group	Role	What they receive
Levetiracetam (LEV)	Experimental	LEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day. Receives: Drug: Levetiracetam
Placebo	Placebo comparator	Subjects received Placebo matching to LEV treatment. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period
Calculated as 7-day partial onset seizure frequency.
Measured: During the 14-weeks Treatment period (Week 8 to Week 22)

Secondary outcomes (16)

50% responder rate in seizure frequency per week during the Treatment Period
Response rate is defined as percent of patients experiencing at least a 50% reduction from baseline in the seizure frequency per week during the Treatment Period.
Measured: During the 14-weeks Treatment period (Week 8 to Week 22)
Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period
Categories as follows: <-25%, -25% to <25%, 25% to <50%, 50% to <75%, 75% to <100%, and 100%
Measured: From Baseline to the 14-weeks Treatment period
Change from baseline in the average duration of seizure free intervals
Intervals are defined as seizure-free if no seizures are reported.
Measured: From Baseline to the 14-weeks Treatment period
Number of seizure free days during the Treatment Period
A day is regarded as seizure-free if no seizures are reported.
Measured: During the 14-weeks Treatment period (Week 8 to Week 22)
Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period
Absolute change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period.
A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.
Measured: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
Absolute change from baseline in partial onset seizure frequency per week during the Titration Period
Absolute change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period.
A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.
Measured: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period
Absolute change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period.
A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.
Measured: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
Percent change from baseline in partial onset seizure frequency per week during the Treatment Period
Percent change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period.
A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.
Measured: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
Percent change from baseline in partial onset seizure frequency per week during the Titration Period
Percent change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period.
A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.
Measured: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period
Percent change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period.
A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.
Measured: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period
A subject was regarded as seizure-free if not seizures were reported since the beginning of the Evaluation Period.
Measured: Beginning of the Evaluation Period (Week 14)
Partial onset seizure frequency per week during the Titration Period
Calculated as 7-day partial onset seizure frequency.
Measured: During the 6-weeks Titration period (Week 8 to Week 14)
Partial onset seizure frequency per week during the Evaluation Period
Calculated as 7-day partial onset seizure frequency.
Measured: During the 6-weeks Evaluation period (Week 8 to Week 14)
Total seizure frequency per week (Types I + II + III) during the Treatment Period
Calculated as 7-day partial onset seizure frequency.
Measured: During the 14-weeks Treatment period (Week 8 to Week 22)
Total seizure frequency per week (Types I + II + III) during the Titration Period
Calculated as 7-day partial onset seizure frequency.
Measured: During the 6-weeks Titration period (Week 8 to Week 14)
Total seizure frequency per week (Types I + II + III) during the Evaluation Period
Calculated as 7-day partial onset seizure frequency.
Measured: During the 6-weeks Evaluation period (Week 8 to Week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 1999Mar 2003

First posted14 Feb 2008 (estimated)
Study startSep 1999
Primary completionMar 2003
Study completionMar 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615615
Sponsor's protocol ID: N159
Status last verified: Jul 2020
First submitted: 27 Jan 2008
Last updated: 30 Jul 2020
Results posted: No
Data monitoring committee: No

Publications

Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z; N159 Study Group. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology. 2006 Jun 13;66(11):1654-60. doi: 10.1212/01.wnl.0000217916.00225.3a. Epub 2006 Apr 26.
PubMed 16641323
Jensen FE, Bourgeois BF. Randomized trial supports use of levetiracetam adjunctive therapy to treat partial seizures in children. Nat Clin Pract Neurol. 2006 Nov;2(11):596-7. doi: 10.1038/ncpneuro0325. No abstract available.
PubMed 17057745
Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3.
PubMed 34033237

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial
ClinicalTrials.gov ID: NCT00615615
Acronym / sponsor ID: N159
Conditions: Epilepsy
Keywords: Levetiracetam, Keppra
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Sep 1999 (actual)
Primary completion: Mar 2003 (actual)
Study completion: Mar 2003 (actual)
First posted: 14 Feb 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.

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Levetiracetam (LEV)	Experimental	Drug: LevetiracetamLEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day.
Placebo	Placebo comparator	Drug: PlaceboSubjects received Placebo matching to LEV treatment.

Who may qualify

Ages: 4 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit
epilepsy was classifiable according to the ILAE Classification
>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
unsatisfactory current AED treatment in terms of efficacy and/or safety
stable AED treatment consisting of no more than two AEDs

Key exclusion criteria (5 listed)

treatable seizure etiology
epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
history of or the presence of pseudo seizures
current diagnosis of Lennox-Gastaut syndrome

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* high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg * low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less	Drug	Levetiracetam (LEV)
PlaceboPlacebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy	Drug	Placebo

Primary outcome

Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period
Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)
Calculated as 7-day partial onset seizure frequency.

16 secondary outcomes

50% responder rate in seizure frequency per week during the Treatment Period
Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)
Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period
Time frame: From Baseline to the 14-weeks Treatment period
Change from baseline in the average duration of seizure free intervals
Time frame: From Baseline to the 14-weeks Treatment period
Number of seizure free days during the Treatment Period
Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)
Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period
Time frame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
Absolute change from baseline in partial onset seizure frequency per week during the Titration Period
Time frame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period
Time frame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
Percent change from baseline in partial onset seizure frequency per week during the Treatment Period
Time frame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
Percent change from baseline in partial onset seizure frequency per week during the Titration Period
Time frame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period
Time frame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period
Time frame: Beginning of the Evaluation Period (Week 14)
Partial onset seizure frequency per week during the Titration Period
Time frame: During the 6-weeks Titration period (Week 8 to Week 14)
Partial onset seizure frequency per week during the Evaluation Period
Time frame: During the 6-weeks Evaluation period (Week 8 to Week 14)
Total seizure frequency per week (Types I + II + III) during the Treatment Period
Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)
Total seizure frequency per week (Types I + II + III) during the Titration Period
Time frame: During the 6-weeks Titration period (Week 8 to Week 14)
Total seizure frequency per week (Types I + II + III) during the Evaluation Period
Time frame: During the 6-weeks Evaluation period (Week 8 to Week 14)

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 30 Jul 2020.
Background: PubMed 16641323Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z; N159 Study Group. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology. 2006 Jun 13;66(11):1654-60. doi: 10.1212/01.wnl.0000217916.00225.3a. Epub 2006 Apr 26.
Background: PubMed 17057745Jensen FE, Bourgeois BF. Randomized trial supports use of levetiracetam adjunctive therapy to treat partial seizures in children. Nat Clin Pract Neurol. 2006 Nov;2(11):596-7. doi: 10.1038/ncpneuro0325. No abstract available.
Derived from this study: PubMed 34033237Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

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 Cares study director

+1 844 599 2273 (UCB)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levetiracetam in people with Epilepsy, 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 5 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 30 Jul 2020. 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. 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?

Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period (time frame: During the 14-weeks Treatment period (Week 8 to Week 22)). 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 NCT00615615, which also lists 3 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 30 Jul 2020.