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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001997-13 | EudraCT Number |
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An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam 166 mg | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period | Evaluation Period | |
| Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period | Evaluation Period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period | From Visit 1 to the end of the Evaluation Period | |
| Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877-822-9493 | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22050371 | Derived | Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2. |
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| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| 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 |
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| Levetiracetam 250 mg | Drug |
|
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| Levetiracetam 500 mg | Drug |
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| From Visit 1 to the end of the Evaluation Period |
| Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types | From N01057 or N166 Baseline to the Evaluation Period |
| Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types | From N01057 or N166 Baseline to the Evaluation Period |
| Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations | From N01057 or N166 Baseline to the Evaluation Period |
| Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations | From N01057 or N166 Baseline to the Evaluation Period |
| Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations | Evaluation Period |
| Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types | Evaluation Period |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |