Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

NCT ID: NCT00630357

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2004-07-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Levetiracetam (Keppra)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

UCB

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Other Identifiers

N01037

Identifier Type: -

Identifier Source: org_study_id