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

Phase 3

Completed

• Conditions: Generalized Tonic-clonic Seizures; Epilepsy
• Interventions: Drug: Levetiracetam

• Registration Number: NCT01292837
• Lead Sponsor: UCB Japan Co. Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-06-03
• Results First Submitted QC: 2014-07-21
• Results First Posted: 2014-08-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Twice daily (morning and evening) orally

Primary Outcome Measures

Name	Time	Method
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)	From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)	The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.; The percent change from Baseline = (B - T)/B x 100; The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7

Secondary Outcome Measures

Name	Time	Method
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period	From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)	The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.; The percent change from Baseline = (B - E)/B x 100; The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7
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	From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)	The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period	From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)	The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
Generalized Tonic-clonic Seizure Freedom Over the Treatment Period	Treatment Period (Week 0 to Week 24)	A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period	Evaluation Period (Week 4 to Week 24)	A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.

Trial Locations

Locations (26)

184; 🇯🇵 Bunkyo, Japan

303; 🇯🇵 Hiroshima, Japan

309; 🇯🇵 Bunkyo, Japan

107; 🇯🇵 Gifu, Japan

108; 🇯🇵 Kobe, Japan

307; 🇯🇵 Shizuoka, Japan

136; 🇯🇵 Moriyama, Japan

190; 🇯🇵 Nerima, Japan

116; 🇯🇵 Ohmura, Japan

119; 🇯🇵 Saitama, Japan

302; 🇯🇵 Kodaira, Japan

306; 🇯🇵 Koshi, Japan

308; 🇯🇵 Onojo, Japan

305; 🇯🇵 Nagoya, Japan

125; 🇯🇵 Neyagawa, Japan

301; 🇯🇵 Niigata, Japan

191; 🇯🇵 Akita, Japan

117; 🇯🇵 Sapporo, Japan

138; 🇯🇵 Shimotsuke, Japan

304; 🇯🇵 Sapporo, Japan

103; 🇯🇵 Sendai, Japan

310; 🇯🇵 Yufu, Japan

135; 🇯🇵 Tsu, Japan

109; 🇯🇵 Okayama, Japan

139; 🇯🇵 Takatsuki, Japan

193; 🇯🇵 Yokohama, Japan