NCT Number: NCT00630357
Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in 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.
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Notify MeKey information
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Investigate seizure freedom with Keppra flexible dose.
Secondary outcomes
-
Tolerability and safety.
Sponsors and collaborators
Lead sponsor
UCB Pharma
Industry
Registry information
Official study 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
Important dates
- Study start
- 2003
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Mar 7, 2008
- Registry last updated
- Nov 15, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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