Status:
COMPLETED
S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
1541 Patients enrolled
Trial Details
Trial ID
NCT00630968
Start Date
August 1 2000
End Date
February 1 2004
Last Update
November 15 2013
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