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

NCT ID: NCT01498822

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-07-31

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

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

Levetiracetam twice a day treatment group

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

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

Oxcarbazepine

Oxcarbazepine twice a day treatment group

Group Type: ACTIVE_COMPARATOR

Oxcarbazepine

Intervention Type: DRUG

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)

Interventions

Levetiracetam

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

Oxcarbazepine

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)

Intervention Type: DRUG

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea UCB Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

05

Busan, , South Korea

10

Busan, , South Korea

16

Busan, , South Korea

06

Daejeon, , South Korea

18

Daejeon, , South Korea

23

Gangwon-Do, , South Korea

08

Goyang-si, , South Korea

09

Goyang-si, , South Korea

07

Gwangju, , South Korea

22

Junggu, , South Korea

14

Seongnam-si, , South Korea

01

Seoul, , South Korea

02

Seoul, , South Korea

03

Seoul, , South Korea

04

Seoul, , South Korea

11

Seoul, , South Korea

12

Seoul, , South Korea

13

Seoul, , South Korea

15

Seoul, , South Korea

17

Seoul, , South Korea

20

Seoul, , South Korea

21

Seoul, , South Korea

19

Ulsan, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28395124 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2014-002713-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01367

Identifier Type: -

Identifier Source: org_study_id