search
Back to results

A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

Primary Purpose

Epilepsies, Partial

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam 250 mg
Levetiracetam 500 mg
Placebo
Sponsored by
UCB Japan Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Partial focused on measuring Epilepsies, Partial,, Keppra, levetiracetam

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Epileptic patients who fulfill the following criteria are eligible for inclusion in the study: Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks Exclusion Criteria: The following patients are not eligible for inclusion into the study: Subjects who were diagnosed with status epilepticus within 3 months before screening Subjects with no partial seizures of which frequency was measured during the Baseline Period Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study Subjects with a history of oral treatment with Levetiracetam (LEV)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lev 0.5 g

Lev 1 g

Lev 2 g

Lev 3 g

Placebo

Arm Description

Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

Outcomes

Primary Outcome Measures

Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period

Secondary Outcome Measures

Partial (Type I) seizure frequency per week over the Evaluation Period
Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period
Seizure freedom over the Evaluation Period
Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period

Full Information

First Posted
January 19, 2006
Last Updated
February 10, 2015
Sponsor
UCB Japan Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00280696
Brief Title
A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
Official Title
A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
Epilepsies, Partial,, Keppra, levetiracetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lev 0.5 g
Arm Type
Experimental
Arm Description
Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Arm Title
Lev 1 g
Arm Type
Experimental
Arm Description
Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Arm Title
Lev 2 g
Arm Type
Experimental
Arm Description
Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Arm Title
Lev 3 g
Arm Type
Experimental
Arm Description
Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention Type
Drug
Intervention Name(s)
Levetiracetam 250 mg
Other Intervention Name(s)
Keppra
Intervention Description
Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 250 mg Route of Administration: Oral Use
Intervention Type
Drug
Intervention Name(s)
Levetiracetam 500 mg
Other Intervention Name(s)
Keppra
Intervention Description
Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 500 mg Route of Administration: Oral Use
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Active Substance: Placebo Pharmaceutical Form: Film-coated tablet Concentration: 250 mg and 500 mg Route of Administration: Oral Use
Primary Outcome Measure Information:
Title
Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
Time Frame
From Baseline to the 12-week Evaluation Period
Secondary Outcome Measure Information:
Title
Partial (Type I) seizure frequency per week over the Evaluation Period
Time Frame
12-week Evaluation Period
Title
Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period
Time Frame
From Baseline to the 12-week Evaluation Period
Title
Seizure freedom over the Evaluation Period
Time Frame
12-week Evaluation Period
Title
Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
Time Frame
From Baseline to the 12-week Evaluation Period
Title
Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period
Time Frame
From Baseline to the 12-week Evaluation Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Epileptic patients who fulfill the following criteria are eligible for inclusion in the study: Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks Exclusion Criteria: The following patients are not eligible for inclusion into the study: Subjects who were diagnosed with status epilepticus within 3 months before screening Subjects with no partial seizures of which frequency was measured during the Baseline Period Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study Subjects with a history of oral treatment with Levetiracetam (LEV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Aichi-gun
State/Province
Aichi
Country
Japan
City
Nagoya
State/Province
Aichi
Country
Japan
City
Nayoga
State/Province
Aichi
Country
Japan
City
Hirosaki
State/Province
Aomori
Country
Japan
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Fukuyama
State/Province
Hiroshima
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Hakodate
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Kahoku-gun
State/Province
Ishikawa
Country
Japan
City
Kikuchi-gun
State/Province
Kumamoto
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Omura
State/Province
Nagasaki
Country
Japan
City
Izumi
State/Province
Osaka
Country
Japan
City
Neyagawa
State/Province
Osaka
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Kawachi-gun
State/Province
Tochigi
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Ube
State/Province
Yamaguchi
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Gihu
Country
Japan
City
Hiroshima
Country
Japan
City
Kagoshima
Country
Japan
City
Kobe
Country
Japan
City
Kyoto
Country
Japan
City
Miyazaki
Country
Japan
City
Nagaoka
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Shizuoka
Country
Japan
City
Tokyo
Country
Japan
City
Toyama
Country
Japan
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25854635
Citation
Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13.
Results Reference
derived

Learn more about this trial

A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

We'll reach out to this number within 24 hrs