Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Levetiracetam (Drug); Oxcarbazepine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Korea UCB Co., Ltd. Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Subjects With a Treatment Failure
Secondary outcome: 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 PeriodPercentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period
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
Eligibility
Minimum age: 16 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
Locations and Contacts
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, Korea, Republic of
Additional Information
FDA Safety Alerts and Recalls Product Information
Starting date: June 2011
Last updated: July 24, 2015
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