Clinical trial NCT01292837: A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
Official title: An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Generalized Tonic-clonic Seizures
Keywords: Levetiracetam
Epilepsy
Generalized tonic-clonic seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 13
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).


Eligibility criteria: Inclusion Criteria:

* An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
* A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period

Exclusion Criteria:

* Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
* Diagnosis of Lennox-Gastaut Syndrome
* Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
* A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

Primary outcomes:
measure: The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
timeFrame: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
Secondary outcomes:
measure: The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
timeFrame: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
measure: Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
timeFrame: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
measure: Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
timeFrame: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
measure: Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
timeFrame: Treatment Period (Week 0 to Week 24)
measure: Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
timeFrame: Evaluation Period (Week 4 to Week 24)
Other outcomes:
Locations:
city: Akita
country: Japan
facility: 191
city: Bunkyo
country: Japan
facility: 184
city: Bunkyo
country: Japan
facility: 309
city: Gifu
country: Japan
facility: 107
city: Hiroshima
country: Japan
facility: 303
city: Kobe
country: Japan
facility: 108
city: Kodaira
country: Japan
facility: 302
city: Koshi
country: Japan
facility: 306
city: Moriyama
country: Japan
facility: 136
city: Nagoya
country: Japan
facility: 305
city: Nerima
country: Japan
facility: 190
city: Neyagawa
country: Japan
facility: 125
city: Niigata
country: Japan
facility: 301
city: Ohmura
country: Japan
facility: 116
city: Okayama
country: Japan
facility: 109
city: Onojo
country: Japan
facility: 308
city: Saitama
country: Japan
facility: 119
city: Sapporo
country: Japan
facility: 117
city: Sapporo
country: Japan
facility: 304
city: Sendai
country: Japan
facility: 103
city: Shimotsuke
country: Japan
facility: 138
city: Shizuoka
country: Japan
facility: 307
city: Takatsuki
country: Japan
facility: 139
city: Tsu
country: Japan
facility: 135
city: Yokohama
country: Japan
facility: 193
city: Yufu
country: Japan
facility: 310
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: