Clinical trial NCT01063764: An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Official title: An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Partial Seizures
Keywords: Keppra
Levetiracetam
Children
Epilepsy
Partial Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Detailed description: Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Eligibility criteria: Inclusion Criteria:

* The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
* The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
* Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion Criteria:

* The patient has a treatable seizure etiology
* The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
* The patient has a history of status Epilepticus during the 3 months prior to Visit 1
* The patient has a past and present history of pseudo seizures
* The patient has a current diagnosis of Lennox-Gastaut syndrome

Primary outcomes:
measure: Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
timeFrame: From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
timeFrame: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
Secondary outcomes:
measure: Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
timeFrame: From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
measure: Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
timeFrame: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
measure: Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
timeFrame: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
measure: Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
timeFrame: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
measure: Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
timeFrame: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
measure: Number of Seizure-free Subjects Over the 14-weeks Treatment Period
timeFrame: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
measure: Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
timeFrame: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
measure: Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)
timeFrame: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
measure: Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)
timeFrame: From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)
Other outcomes:
Locations:
city: Chuo
country: Japan
facility: 21
city: Hakodate
country: Japan
facility: 12
city: Hamamatsu
country: Japan
facility: 22
city: Hiroshima
country: Japan
facility: 28
city: Izumi
country: Japan
facility: 7
city: Kobe
country: Japan
facility: 9
city: Kodaira
country: Japan
facility: 3
city: Koga
country: Japan
facility: 30
city: Koushi
country: Japan
facility: 10
city: Kurume
country: Japan
facility: 31
city: Kyoto
country: Japan
facility: 23
city: Nagaoka
country: Japan
facility: 2
city: Nagoya
country: Japan
facility: 5
city: Nagoya
country: Japan
facility: 6
city: Neyagawa
country: Japan
facility: 8
city: Niigata
country: Japan
facility: 1
city: Okayama
country: Japan
facility: 27
city: Osaka
country: Japan
facility: 24
city: Osaka
country: Japan
facility: 25
city: Sapporo
country: Japan
facility: 11
city: Sendai
country: Japan
facility: 13
city: Shizuoka
country: Japan
facility: 4
city: Takatsuki
country: Japan
facility: 26
city: Tokyo
country: Japan
facility: 16
city: Tokyo
country: Japan
facility: 17
city: Yachiyo
country: Japan
facility: 15
city: Yamagata
country: Japan
facility: 14
city: Yokohama
country: Japan
facility: 19
city: Yokohama
country: Japan
facility: 20
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Nakamura H, Osawa M, Yokoyama T, Yoshida K, Suzuki A. [Efficacy and safety of levetiracetam as adjunctive therapy in Japanese children with uncontrolled partial-onset seizures: multicenter and open-label study (N01223), short term evaluation]. Brain Nerve. 2013 Sep;65(9):1083-92. Japanese.