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

Epilepsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498822
• Other study ID #: N01367
• Secondary ID: 2014-002713-32
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2011
• Last updated: July 24, 2015
• Start date: June 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• 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
• 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)

Locations

Country	Name	City	State
Korea, Republic of	05	Busan
Korea, Republic of	10	Busan
Korea, Republic of	16	Busan
Korea, Republic of	06	Daejeon
Korea, Republic of	18	Daejeon
Korea, Republic of	23	Gangwon-Do
Korea, Republic of	08	Goyang-si
Korea, Republic of	09	Goyang-si
Korea, Republic of	07	Gwangju
Korea, Republic of	22	Jung-Gu
Korea, Republic of	14	Seongnam-si
Korea, Republic of	01	Seoul
Korea, Republic of	02	Seoul
Korea, Republic of	03	Seoul
Korea, Republic of	04	Seoul
Korea, Republic of	11	Seoul
Korea, Republic of	12	Seoul
Korea, Republic of	13	Seoul
Korea, Republic of	15	Seoul
Korea, Republic of	17	Seoul
Korea, Republic of	20	Seoul
Korea, Republic of	21	Seoul
Korea, Republic of	19	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Korea UCB Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0 (First Dose) to Week 50	No
Secondary	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		From Week 2 to Week 50 (During Treatment Period )	No
Secondary	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	From Week 2 to Week 50 (During Treatment Period )	No
Secondary	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	From Week 2 to Week 50 (During Treatment Period )	No

External Links

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