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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 Period

Percentage 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

Page last updated: August 23, 2015

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