Official Title: “A Phase IV, Open-Label, Multi-Center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-Therapy in Adult Subjects With Partial Epilepsy”

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.

Study Type: Interventional

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

Study Primary Completion Date: July 2004

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam (Keppra)

Primary Measures

• Investigate seizure freedom with Keppra flexible dose.

Secondary Measures

• Tolerability and safety.

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.

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630357

Study ID Number: N01037

ClinicalTrials.gov Identifier: NCT00630357

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration