Back to resultsTrial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levetiracetam (Keppra)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Keppra
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Investigate seizure freedom with Keppra flexible dose.
Secondary Outcome Measures
Tolerability and safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00630357
Brief Title
Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Levetiracetam, Keppra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam (Keppra)
Primary Outcome Measure Information:
Title
Investigate seizure freedom with Keppra flexible dose.
Secondary Outcome Measure Information:
Title
Tolerability and safety.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy
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