A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
- Conditions
- EpilepsyGeneralized Tonic-Clonic Seizures
- Interventions
- Drug: Placebo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 361
- 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
- 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
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 BaselineGeneralized 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