A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

NCT ID: NCT01292837

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-06-30

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).

Conditions

Epilepsy; Generalized Tonic-clonic Seizures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

Twice daily (morning and evening) orally

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Interventions

Levetiracetam

The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Intervention Type: DRUG

Other Intervention Names

Keppra; E Keppra

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

191

Akita, , Japan

184

Bunkyō City, , Japan

309

Bunkyō City, , Japan

107

Gifu, , Japan

303

Hiroshima, , Japan

108

Kobe, , Japan

302

Kodaira, , Japan

306

Kōshi, , Japan

136

Moriyama, , Japan

305

Nagoya, , Japan

190

Nerima City, , Japan

125

Neyagawa, , Japan

301

Niigata, , Japan

116

Ohmura, , Japan

109

Okayama, , Japan

308

Ōnojō, , Japan

119

Saitama, , Japan

117

Sapporo, , Japan

304

Sapporo, , Japan

103

Sendai, , Japan

138

Shimotsuke, , Japan

307

Shizuoka, , Japan

139

Takatsuki, , Japan

135

Tsu, , Japan

193

Yokohama, , Japan

310

Yufu, , Japan

Countries

Japan

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA safety Alerts and Recalls

Other Identifiers

2014-004382-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01363

Identifier Type: -

Identifier Source: org_study_id