S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
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|ClinicalTrials.gov Identifier: NCT00630968|
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 15, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Levetiracetam (Keppra)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1541 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
- Percentage reduction in seizure frequency. [ Time Frame: 16-week treatment period ]
- To further assess safety.
- The patient-weighted Quality Of Life In Epilepsy inventory.
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630968
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|
|Responsible Party:||Study Director, UCB|
|Other Study ID Numbers:||
|First Posted:||March 7, 2008 Key Record Dates|
|Last Update Posted:||November 15, 2013|
|Last Verified:||September 2009|
Central Nervous System Diseases
Nervous System Diseases