Official Title: “Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2004

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam (Keppra)

Primary Measures

• Percentage reduction in seizure frequency.
  • Time Frame: 16-week treatment period
    

Secondary Measures

• To further assess safety.
• The patient-weighted Quality Of Life In Epilepsy inventory.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630968

Study ID Number: N01031

ClinicalTrials.gov Identifier: NCT00630968

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products