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Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy (OPTIMAL)

Primary Purpose

Epilepsy

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

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Oxcarbazepine, treatment failure, partial epilepsy

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. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
  • Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
  • Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
  • Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
  • Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

Exclusion Criteria:

  • Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
  • Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
  • Subject taking any immunosuppressant within 28 days prior to Visit 1
  • Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
  • Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
  • Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
  • Subject has a history of status epilepticus within last 3-month period prior to Visit 1
  • Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period
  • Body weight is lower than 40 kg (< 40 kg)

Sites / Locations

  • 05
  • 10
  • 16
  • 06
  • 18
  • 23
  • 08
  • 09
  • 07
  • 22
  • 14
  • 01
  • 02
  • 03
  • 04
  • 11
  • 12
  • 13
  • 15
  • 17
  • 20
  • 21
  • 19

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levetiracetam

Oxcarbazepine

Arm Description

Levetiracetam twice a day treatment group

Oxcarbazepine twice a day treatment group

Outcomes

Primary Outcome Measures

Percentage of Subjects With a Treatment Failure
Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.

Secondary Outcome Measures

Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period
Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time
24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time
Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period
48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period

Full Information

First Posted
December 21, 2011
Last Updated
July 24, 2015
Sponsor
Korea UCB Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01498822
Brief Title
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Acronym
OPTIMAL
Official Title
A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose
Detailed Description
The study duration consists of the following periods: Baseline period of one week: Week -1 Titration period of two weeks: Week 0 to Week 1 Treatment period of 48 weeks: Week 2 to Week 50

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Levetiracetam, Oxcarbazepine, treatment failure, partial epilepsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Levetiracetam twice a day treatment group
Arm Title
Oxcarbazepine
Arm Type
Active Comparator
Arm Description
Oxcarbazepine twice a day treatment group
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Intervention Description
150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)
Primary Outcome Measure Information:
Title
Percentage of Subjects With a Treatment Failure
Description
Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.
Time Frame
Week 0 (First Dose) to Week 50
Secondary Outcome Measure Information:
Title
Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period
Time Frame
From Week 2 to Week 50 (During Treatment Period )
Title
Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time
Description
24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time
Time Frame
From Week 2 to Week 50 (During Treatment Period )
Title
Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period
Description
48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period
Time Frame
From Week 2 to Week 50 (During Treatment Period )

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. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1) Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1 Exclusion Criteria: Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics Subject taking any immunosuppressant within 28 days prior to Visit 1 Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs) Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures Subject has a history of status epilepticus within last 3-month period prior to Visit 1 Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period Body weight is lower than 40 kg (< 40 kg)
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
05
City
Busan
Country
Korea, Republic of
Facility Name
10
City
Busan
Country
Korea, Republic of
Facility Name
16
City
Busan
Country
Korea, Republic of
Facility Name
06
City
Daejeon
Country
Korea, Republic of
Facility Name
18
City
Daejeon
Country
Korea, Republic of
Facility Name
23
City
Gangwon-Do
Country
Korea, Republic of
Facility Name
08
City
Goyang-si
Country
Korea, Republic of
Facility Name
09
City
Goyang-si
Country
Korea, Republic of
Facility Name
07
City
Gwangju
Country
Korea, Republic of
Facility Name
22
City
Jung-Gu
Country
Korea, Republic of
Facility Name
14
City
Seongnam-si
Country
Korea, Republic of
Facility Name
01
City
Seoul
Country
Korea, Republic of
Facility Name
02
City
Seoul
Country
Korea, Republic of
Facility Name
03
City
Seoul
Country
Korea, Republic of
Facility Name
04
City
Seoul
Country
Korea, Republic of
Facility Name
11
City
Seoul
Country
Korea, Republic of
Facility Name
12
City
Seoul
Country
Korea, Republic of
Facility Name
13
City
Seoul
Country
Korea, Republic of
Facility Name
15
City
Seoul
Country
Korea, Republic of
Facility Name
17
City
Seoul
Country
Korea, Republic of
Facility Name
20
City
Seoul
Country
Korea, Republic of
Facility Name
21
City
Seoul
Country
Korea, Republic of
Facility Name
19
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28395124
Citation
Kim JH, Lee SK, Loesch C, Namgoong K, Lee HW, Hong SB; Korean N01367 Study Group. Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial. Epilepsia. 2017 Apr;58(4):e70-e74. doi: 10.1111/epi.13707.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

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