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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004333-57 | EudraCT Number |
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A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lev 0.5 g | Experimental | Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). |
|
| Lev 1 g | Experimental | Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). |
|
| Lev 2 g | Experimental | Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). |
|
| Lev 3 g | Experimental | Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). |
|
| Placebo | Placebo Comparator | Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam 250 mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period | From Baseline to the 12-week Evaluation Period |
| Measure | Description | Time Frame |
|---|---|---|
| Partial (Type I) seizure frequency per week over the Evaluation Period | 12-week Evaluation Period | |
| Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period | From Baseline to the 12-week Evaluation Period |
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Inclusion Criteria:
Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:
Exclusion Criteria:
The following patients are not eligible for inclusion into the study:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi-gun | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25854635 | Derived | Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13. |
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|
|
| Levetiracetam 500 mg | Drug |
|
|
|
| Placebo | Other |
|
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| Seizure freedom over the Evaluation Period | 12-week Evaluation Period |
| Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period | From Baseline to the 12-week Evaluation Period |
| Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period | From Baseline to the 12-week Evaluation Period |
| Nagoya |
| Aichi-ken |
| Japan |
| Nayoga | Aichi-ken | Japan |
| Hirosaki | Aomori | Japan |
| Chiba | Chiba | Japan |
| Fukuoka | Fukuoka | Japan |
| Kitakyushu | Fukuoka | Japan |
| Kurume | Fukuoka | Japan |
| Gifu | Gihu | Japan |
| Fukuyama | Hiroshima | Japan |
| Hiroshima | Hiroshima | Japan |
| Asahikawa | Hokkaido | Japan |
| Hakodate | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Kahoku-gun | Ishikawa-ken | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Kikuchi-gun | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Sendai | Miyagi | Japan |
| Miyazaki | Miyazaki | Japan |
| Nagaoka | Nagaoka | Japan |
| Ōmura | Nagasaki | Japan |
| Niigata | Niigata | Japan |
| Okayama | Okayama-ken | Japan |
| Izumi | Osaka | Japan |
| Neyagawa | Osaka | Japan |
| Osaka | Osaka | Japan |
| Suita | Osaka | Japan |
| Shizuoka | Shizuoka | Japan |
| Kawachi-gun | Tochigi | Japan |
| Kodaira | Tokyo | Japan |
| Tokyo | Tokyo | Japan |
| Toyama | Toyama | Japan |
| Yamagata | Yamagata | Japan |
| Ube | Yamaguchi | Japan |
| Kobe | Japan |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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