A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

Phase 3

Completed

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

• Registration Number: NCT01228747
• Lead Sponsor: UCB Japan Co. Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Results First Submitted: 2015-04-27
• Results First Submitted QC: 2015-04-27
• Results First Posted: 2015-05-13
• Status Verified: 2018-12
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

Inclusion Criteria

• An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE 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 and during the combined baseline period

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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 imagining features
• A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo for 28 weeks
Levetiracetam	Levetiracetam	Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Primary Outcome Measures

Name	Time	Method
Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)	From Baseline to Week 28	Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)\*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline

Secondary Outcome Measures

Name	Time	Method
The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period	From Baseline to Evaluation Period (Week 12 to Week 28)	Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)\*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline.
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 to Week 28	A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period	Evaluation Period (Week 12 to Week 28)	A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.
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 Evaluation Period	From Baseline to Evaluation Period (Week 12 to Week 28)	A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline

Trial Locations

Locations (58)

152; 🇯🇵 Fujisawa, Japan

170; 🇯🇵 Saito, Japan

153; 🇯🇵 Kashiwakazi, Japan

17; 🇨🇳 Shenyang, China

105; 🇯🇵 Kokubunji, Japan

129; 🇯🇵 Osaka-sayama, Japan

117; 🇯🇵 Sapporo, Japan

194; 🇯🇵 Sakai, Japan

304; 🇯🇵 Sapporo, Japan

12; 🇨🇳 Changchun, China

19; 🇨🇳 Chengdu, China

6; 🇨🇳 Chengdu, China

10; 🇨🇳 Chongqing, China

1; 🇨🇳 Beijing, China

9; 🇨🇳 Beijing, China

16; 🇨🇳 Guangzhou, China

5; 🇨🇳 Guangzhou, China

18; 🇨🇳 Harbin, China

13; 🇨🇳 Kunming, China

14; 🇨🇳 Qingdao, China

2; 🇨🇳 Shanghai, China

3; 🇨🇳 Shanghai, China

15; 🇨🇳 Taiyuan, China

8; 🇨🇳 Wuhan, China

7; 🇨🇳 Xi'an, China

20; 🇨🇳 Xian, China

131; 🇯🇵 Sapporo, Japan

111; 🇯🇵 Ube, Japan

179; 🇯🇵 Miyazaki, Japan

143; 🇯🇵 Kagoshima, Japan

187; 🇯🇵 Fukushima, Japan

124; 🇯🇵 Hamamatsu, Japan

150; 🇯🇵 Kashihara, Japan

172; 🇯🇵 Miyakonojo, Japan

189; 🇯🇵 Nagoya, Japan

157; 🇯🇵 Osaka, Japan

147; 🇯🇵 Sakai, Japan

120; 🇯🇵 Tokyo, Japan

112; 🇯🇵 Fukuoka, Japan

113; 🇯🇵 Fukuoka, Japan

175; 🇯🇵 Higashiosaka, Japan

162; 🇯🇵 Himeji, Japan

177; 🇯🇵 Hiroshima, Japan

156; 🇯🇵 Kagoshima, Japan

130; 🇯🇵 Otaru, Japan

168; 🇯🇵 Shimajiri, Japan

138; 🇯🇵 Shimotsuke, Japan

165; 🇯🇵 Iizuka, Japan

176; 🇯🇵 Kameda, Japan

186; 🇯🇵 Miyazaki, Japan

158; 🇯🇵 Okayama, Japan

103; 🇯🇵 Sendai, Japan

121; 🇯🇵 Shizuoka, Japan

166; 🇯🇵 Fukuoka, Japan

110; 🇯🇵 Hiroshima, Japan

106; 🇯🇵 Niigata, Japan

174; 🇯🇵 Osaka, Japan

22; 🇨🇳 Nanjing, China