A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
NCT ID: NCT01228747
Last Updated: 2025-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
361 participants
INTERVENTIONAL
2010-10-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Matching placebo for 28 weeks
Placebo
Matching oral placebo tablets twice daily for 28 weeks
Levetiracetam
Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Levetiracetam
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Interventions
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Levetiracetam
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Placebo
Matching oral placebo tablets twice daily for 28 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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UCB Japan Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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1
Beijing, , China
9
Beijing, , China
12
Changchun, , China
19
Chengdu, , China
6
Chengdu, , China
10
Chongqing, , China
16
Guangzhou, , China
5
Guangzhou, , China
18
Harbin, , China
13
Kunming, , China
22
Nanjing, , China
14
Qingdao, , China
2
Shanghai, , China
3
Shanghai, , China
17
Shenyang, , China
15
Taiyuan, , China
8
Wuhan, , China
20
Xi'an, , China
7
Xi'an, , China
152
Fujisawa, , Japan
112
Fukuoka, , Japan
113
Fukuoka, , Japan
166
Fukuoka, , Japan
187
Fukushima, , Japan
124
Hamamatsu, , Japan
175
Higashiosaka, , Japan
162
Himeji, , Japan
110
Hiroshima, , Japan
177
Hiroshima, , Japan
165
Iizuka, , Japan
143
Kagoshima, , Japan
156
Kagoshima, , Japan
176
Kameda, , Japan
150
Kashihara, , Japan
153
Kashiwakazi, , Japan
105
Kokubunji, , Japan
172
Miyakonojō, , Japan
179
Miyazaki, , Japan
186
Miyazaki, , Japan
189
Nagoya, , Japan
106
Niigata, , Japan
158
Okayama, , Japan
157
Osaka, , Japan
174
Osaka, , Japan
130
Otaru, , Japan
129
Ōsaka-sayama, , Japan
170
Saito, , Japan
147
Sakai, , Japan
194
Sakai, , Japan
117
Sapporo, , Japan
131
Sapporo, , Japan
304
Sapporo, , Japan
103
Sendai, , Japan
168
Shimajiri, , Japan
138
Shimotsuke, , Japan
121
Shizuoka, , Japan
120
Tokyo, , Japan
111
Ube, , Japan
Countries
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References
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Wu L, Yagi K, Hong Z, Liao W, Wang X, Zhou D, Inoue Y, Ohtsuka Y, Sasagawa M, Terada K, Du X, Muramoto Y, Sano T. Adjunctive levetiracetam in the treatment of Chinese and Japanese adults with generalized tonic-clonic seizures: A double-blind, randomized, placebo-controlled trial. Epilepsia Open. 2018 Sep 29;3(4):474-484. doi: 10.1002/epi4.12255. eCollection 2018 Dec.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-004401-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01159
Identifier Type: -
Identifier Source: org_study_id
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