Epilepsy
Conditions
Keywords
Levetiracetam, Keppra
Brief summary
The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.
Interventions
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Partial onset seizures, whether or not secondarily generalized; * at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline; * using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.
Exclusion criteria
* Presence of known pseudoseizures within the last year; * presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives; * on felbamate with less than 18 months exposure; * on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months; * uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in seizure frequency. | 16-week treatment period |
Secondary
| Measure | Time frame |
|---|---|
| To further assess safety. | — |
| The patient-weighted Quality Of Life In Epilepsy inventory. | — |
Outcome results
None listed