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Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

Primary Purpose

Epilepsy, Partial

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Partial focused on measuring Epilepsy, Partial Onset Seizures, Keppra, Levetiracetam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • N01036 808
  • N01036 842
  • N01036 815
  • N01036 811
  • N01036 812
  • N01036 813
  • N01036 830
  • N01036 831
  • N01036 829
  • N01036 804
  • N01036 806
  • N01036 807
  • N01036 828
  • N01036 827
  • N01036 825
  • N01036 834
  • N01036 835
  • N01036 823
  • N01036 817
  • N01036 818
  • N01036 819
  • N01036 820
  • N01036 821
  • N01036 822
  • N01036 809
  • N01036 840
  • N01036 841
  • N01036 839
  • N01036 810

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam

Arm Description

Subjects received open-label Levetiracetam.

Outcomes

Primary Outcome Measures

Number of Patients With Adverse Events (AEs)
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

Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period
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
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
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
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
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
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.

Full Information

First Posted
September 8, 2005
Last Updated
August 7, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00160654
Brief Title
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Official Title
A Phase IV, Open-label, Multi-center, Community-based Trial in Asia Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 24, 2003 (Actual)
Primary Completion Date
December 12, 2006 (Actual)
Study Completion Date
December 12, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial
Keywords
Epilepsy, Partial Onset Seizures, Keppra, Levetiracetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Subjects received open-label Levetiracetam.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Pharmaceutical form: oral tablets Concentration: 500 mg Route of administration: Oral use
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events (AEs)
Description
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.
Time Frame
From Baseline until Safety visit (two weeks after last dose; up to Week 18)
Secondary Outcome Measure Information:
Title
Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period
Description
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.
Time Frame
Week 16, compared to Baseline
Title
Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period
Description
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.
Time Frame
Week 16, compared to Baseline
Title
Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16
Description
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.
Time Frame
Week 16, compared to Baseline
Title
Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16
Description
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.
Time Frame
Week 16, compared to Baseline
Title
Percentage of Patients With Categorized Change From Baseline in Severity of Illness
Description
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.
Time Frame
Baseline, Week 16
Title
Retention Rate at Week 16
Description
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.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
UCB (+1 844 599 2273)
Official's Role
Study Director
Facility Information:
Facility Name
N01036 808
City
Hong Kong
Country
Hong Kong
Facility Name
N01036 842
City
Hong Kong
Country
Hong Kong
Facility Name
N01036 815
City
Kwun Tong
Country
Hong Kong
Facility Name
N01036 811
City
Kuala Lumpur
Country
Malaysia
Facility Name
N01036 812
City
Kuala Lumpur
Country
Malaysia
Facility Name
N01036 813
City
Kuala Lumpur
Country
Malaysia
Facility Name
N01036 830
City
Manila
Country
Philippines
Facility Name
N01036 831
City
Manila
Country
Philippines
Facility Name
N01036 829
City
Quezon
Country
Philippines
Facility Name
N01036 804
City
Singapore
Country
Singapore
Facility Name
N01036 806
City
Singapore
Country
Singapore
Facility Name
N01036 807
City
Singapore
Country
Singapore
Facility Name
N01036 828
City
Changhua
Country
Taiwan
Facility Name
N01036 827
City
Hualien City
Country
Taiwan
Facility Name
N01036 825
City
Kaohsiung City
Country
Taiwan
Facility Name
N01036 834
City
Kaohsiung
Country
Taiwan
Facility Name
N01036 835
City
Kaohsiung
Country
Taiwan
Facility Name
N01036 823
City
Taichung city
Country
Taiwan
Facility Name
N01036 817
City
Taichung
Country
Taiwan
Facility Name
N01036 818
City
Tainan
Country
Taiwan
Facility Name
N01036 819
City
Taipei
Country
Taiwan
Facility Name
N01036 820
City
Taipei
Country
Taiwan
Facility Name
N01036 821
City
Taipei
Country
Taiwan
Facility Name
N01036 822
City
Taoyuan
Country
Taiwan
Facility Name
N01036 809
City
Bangkok
Country
Thailand
Facility Name
N01036 840
City
Bangkok
Country
Thailand
Facility Name
N01036 841
City
Bangkok
Country
Thailand
Facility Name
N01036 839
City
Chiang Mai
Country
Thailand
Facility Name
N01036 810
City
Khon Kaen
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
20462804
Citation
Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, Tonner F, Beh K, Edrich P; N01036 (SKATE II) Investigator Group. Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study. Epilepsy Behav. 2010 May;18(1-2):100-5. doi: 10.1016/j.yebeh.2010.03.016. Epub 2010 May 11.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

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