Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
- Registration Number
- NCT00160654
- Lead Sponsor
- UCB Pharma
- Brief Summary
Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.
The optimal dose in daily clinical practice will be used.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
- Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
- Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.
- Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
- Presence of known pseudoseizures within the last year.
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
- Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Levetiracetam Levetiracetam Subjects received open-label Levetiracetam.
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Events (AEs) From Baseline until Safety visit (two weeks after last dose; up to Week 18) An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period Week 16, compared to Baseline Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period.
Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.
A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline.Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period Week 16, compared to Baseline Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period.
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.
A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline.Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 Week 16, compared to Baseline 50% response in seizure frequency per Week is defined as \>=50% reduction in seizure frequency from Baseline.
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 Week 16, compared to Baseline 100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline.
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.Percentage of Patients With Categorized Change From Baseline in Severity of Illness Baseline, Week 16 The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening.
Retention Rate at Week 16 Week 16 Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population.
Trial Locations
- Locations (29)
N01036 806
🇸🇬Singapore, Singapore
N01036 818
🇨🇳Tainan, Taiwan
N01036 813
🇲🇾Kuala Lumpur, Malaysia
N01036 829
🇵🇭Quezon, Philippines
N01036 830
🇵🇭Manila, Philippines
N01036 817
🇨🇳Taichung, Taiwan
N01036 819
🇨🇳Taipei, Taiwan
N01036 820
🇨🇳Taipei, Taiwan
N01036 840
🇹🇭Bangkok, Thailand
N01036 821
🇨🇳Taipei, Taiwan
N01036 822
🇨🇳Taoyuan, Taiwan
N01036 809
🇹🇭Bangkok, Thailand
N01036 841
🇹🇭Bangkok, Thailand
N01036 839
🇹🇭Chiang Mai, Thailand
N01036 810
🇹🇭Khon Kaen, Thailand
N01036 825
🇨🇳Kaohsiung City, Taiwan
N01036 812
🇲🇾Kuala Lumpur, Malaysia
N01036 831
🇵🇭Manila, Philippines
N01036 823
🇨🇳Taichung city, Taiwan
N01036 804
🇸🇬Singapore, Singapore
N01036 807
🇸🇬Singapore, Singapore
N01036 828
🇨🇳Changhua, Taiwan
N01036 811
🇲🇾Kuala Lumpur, Malaysia
N01036 827
🇨🇳Hualien City, Taiwan
N01036 834
🇨🇳Kaohsiung, Taiwan
N01036 835
🇨🇳Kaohsiung, Taiwan
N01036 842
🇭🇰Hong Kong, Hong Kong
N01036 808
🇭🇰Hong Kong, Hong Kong
N01036 815
🇭🇰Kwun Tong, Hong Kong