Generalized Epilepsy
Conditions
Keywords
Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam
Brief summary
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.
Interventions
DRUGLevetiracetam 166 mg
* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 166 mg * Route of Administration: Oral use
* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 250 mg * Route of Administration: Oral use
* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 500 mg * Route of Administration: Oral use
Sponsors
UCB Pharma SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV) * Subjects who were/are suffering from primary generalized (type II) epileptic seizures * Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected
Exclusion criteria
* Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol * Concomitant use of any drug with possible central nervous system effects unless at a stable dose * Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | From Visit 1 to the end of the Evaluation Period |
Outcome results
None listed