Epilepsy
Conditions
Keywords
Levetiracetam, Keppra
Brief summary
A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.
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
* Diagnosis of epilepsy with partial seizures; * having completed the trial N01031 of Keppra as adjunctive therapy (SKATE); * seizure-free over the last 3 months prior to protocol Visit 1; * 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031; * on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.
Exclusion criteria
* History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years; * 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; * felbamate with less than 18 months exposure; * vigabatrin, without visual field assessment 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 |
|---|---|
| Investigate seizure freedom with Keppra flexible dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety. | — |
Outcome results
None listed