NCT00630357CompletedPhase 4
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 14
- Primary Endpoint
- Investigate seizure freedom with Keppra flexible dose.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Investigate seizure freedom with Keppra flexible dose.
Secondary Outcomes
- Tolerability and safety.
Investigators
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