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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615615
• Other study ID #: N159
• Status: Completed
• Phase: Phase 3
• Start date: September 1999
• Est. completion date: March 2003

Study information

• Verified date: July 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• 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
• Placebo
Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (2)

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. Epub 2006 Apr 26. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period	Calculated as 7-day partial onset seizure frequency.	During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary	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.	During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary	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%	From Baseline to the 14-weeks Treatment period
Secondary	Change from baseline in the average duration of seizure free intervals	Intervals are defined as seizure-free if no seizures are reported.	From Baseline to the 14-weeks Treatment period
Secondary	Number of seizure free days during the Treatment Period	A day is regarded as seizure-free if no seizures are reported.	During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary	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.	Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary	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.	Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
Secondary	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.	Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
Secondary	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.	Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary	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.	Baseline, During the 6-weeks Titration period (Week 8 to Week 14)
Secondary	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.	Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)
Secondary	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.	Beginning of the Evaluation Period (Week 14)
Secondary	Partial onset seizure frequency per week during the Titration Period	Calculated as 7-day partial onset seizure frequency.	During the 6-weeks Titration period (Week 8 to Week 14)
Secondary	Partial onset seizure frequency per week during the Evaluation Period	Calculated as 7-day partial onset seizure frequency.	During the 6-weeks Evaluation period (Week 8 to Week 14)
Secondary	Total seizure frequency per week (Types I + II + III) during the Treatment Period	Calculated as 7-day partial onset seizure frequency.	During the 14-weeks Treatment period (Week 8 to Week 22)
Secondary	Total seizure frequency per week (Types I + II + III) during the Titration Period	Calculated as 7-day partial onset seizure frequency.	During the 6-weeks Titration period (Week 8 to Week 14)
Secondary	Total seizure frequency per week (Types I + II + III) during the Evaluation Period	Calculated as 7-day partial onset seizure frequency.	During the 6-weeks Evaluation period (Week 8 to Week 14)

External Links

•   Clinical Study Summary on UCB.com