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Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Levetiracetam
Topiramate
Sponsored by
UCB Korea Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring levetiracetam, topiramate, epilepsy, partial seizures

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
  • Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
  • Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
  • Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
  • Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
  • Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
  • Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

  • Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
  • Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
  • Subjects suffering from special syndromes (classification IV according to the ILAE classification)
  • History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
  • Presence of exclusively type IA non-motor seizures.
  • History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
  • History or presence of known pseudo-seizures
  • Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
  • Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)

Sites / Locations

  • 14
  • 21
  • 8
  • 9
  • 12
  • 13
  • 10
  • 25
  • 15
  • 7
  • 11
  • 19
  • 23
  • 24
  • 16
  • 17
  • 18
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 22

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levetiracetam

Topiramate

Arm Description

250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

Outcomes

Primary Outcome Measures

Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate

Secondary Outcome Measures

Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52

Full Information

First Posted
October 26, 2010
Last Updated
July 6, 2017
Sponsor
UCB Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01229735
Brief Title
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Official Title
A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
levetiracetam, topiramate, epilepsy, partial seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
Arm Title
Topiramate
Arm Type
Active Comparator
Arm Description
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
Primary Outcome Measure Information:
Title
Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
Time Frame
From Baseline to Week 52
Secondary Outcome Measure Information:
Title
Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
Time Frame
From Baseline to Week 52
Title
Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Time Frame
From Baseline to Week 52
Title
Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Description
Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
Time Frame
From Baseline to Week 52
Title
Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Time Frame
From Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE). Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2) Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs. Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period. Exclusion Criteria: Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981) Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification) Subjects suffering from special syndromes (classification IV according to the ILAE classification) History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2. Presence of exclusively type IA non-motor seizures. History or presence of status epilepticus within last 3 months preceding V1 or during Baseline History or presence of known pseudo-seizures Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.) Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
14
City
Busan
Country
Korea, Republic of
Facility Name
21
City
Busan
Country
Korea, Republic of
Facility Name
8
City
Busan
Country
Korea, Republic of
Facility Name
9
City
Busan
Country
Korea, Republic of
Facility Name
12
City
Daegu
Country
Korea, Republic of
Facility Name
13
City
Daegu
Country
Korea, Republic of
Facility Name
10
City
Daejeon
Country
Korea, Republic of
Facility Name
25
City
Daejeon
Country
Korea, Republic of
Facility Name
15
City
Gwangju
Country
Korea, Republic of
Facility Name
7
City
Incheon
Country
Korea, Republic of
Facility Name
11
City
Kyunggi-Do
Country
Korea, Republic of
Facility Name
19
City
Kyunggi-do
Country
Korea, Republic of
Facility Name
23
City
Kyunggi-Do
Country
Korea, Republic of
Facility Name
24
City
Kyunggi-Do
Country
Korea, Republic of
Facility Name
16
City
Seoul
Country
Korea, Republic of
Facility Name
17
City
Seoul
Country
Korea, Republic of
Facility Name
18
City
Seoul
Country
Korea, Republic of
Facility Name
1
City
Seoul
Country
Korea, Republic of
Facility Name
2
City
Seoul
Country
Korea, Republic of
Facility Name
3
City
Seoul
Country
Korea, Republic of
Facility Name
4
City
Seoul
Country
Korea, Republic of
Facility Name
5
City
Seoul
Country
Korea, Republic of
Facility Name
6
City
Seoul
Country
Korea, Republic of
Facility Name
22
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

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