Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Korea Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01229735
First received: October 26, 2010
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.


Condition Intervention Phase
Epilepsy
Drug: Levetiracetam
Drug: Topiramate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Adult Subjects With Refractory Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage of subjects continuing the allocated investigational treatment from the first study treatment intake to week 52, after the beginning of investigational treatment with levetiracetam compared to topiramate [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
    Percentage of subjects continuing the allocated investigational treatment from the first study treatment intake to week 52, after the beginning of investigational treatment with levetiracetam compared to topiramate


Secondary Outcome Measures:
  • Number of subjects with at least one adverse event reported during the trial period from baseline to week 52 [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
    Number of subjects with at least one adverse event reported during the trial period from baseline to week 52

  • Time from the first study treatment intake to drug discontinuation due to adverse event (AE) [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
    Time from the first study treatment intake to drug discontinuation due to adverse event (AE)

  • Mean percent reduction in the weekly partial onset seizure (POS) frequency from baseline during the total treatment period from baseline to week 52 [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
    Mean percent reduction in the weekly partial onset seizure (POS) frequency from baseline during the total treatment period from baseline to week 52

  • Responders defined as number of subjects with at least 50% reduction in the weekly POS frequency from baseline during the total treatment period from baseline to week 52 [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
    Responders defined as number of subjects with at least 50% reduction in the weekly POS frequency from baseline during the total treatment period from baseline to week 52


Estimated Enrollment: 340
Study Start Date: November 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
250 mg and 500 mg levetiracetam tablet; up-titration to 1000 mg/day (500 mg bid) levetiracetam with treatment duration up to 52 weeks
Drug: Levetiracetam
250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
Other Name: Keppra
Active Comparator: Topiramate
25 mg and 100 mg topiramate tablet; up-titration to 100 mg/day (50 mg bid) topiramate with treatment duration up to 52 weeks
Drug: Topiramate
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
  • Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
  • Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
  • Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
  • Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
  • Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
  • Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

  • Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
  • Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
  • Subjects suffering from special syndromes (classification IV according to the ILAE classification)
  • History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
  • Presence of exclusively type IA non-motor seizures.
  • History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
  • History or presence of known pseudo-seizures
  • Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
  • Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229735

Locations
Korea, Republic of
20
Anyang, Korea, Republic of
21
Busan, Korea, Republic of
14
Busan, Korea, Republic of
9
Busan, Korea, Republic of
12
Daegu, Korea, Republic of
13
Daegu, Korea, Republic of
25
Daejeon, Korea, Republic of
10
Daejeon, Korea, Republic of
15
Gwangju, Korea, Republic of
7
Incheon, Korea, Republic of
24
Kyunggi-Do, Korea, Republic of
23
Kyunggi-Do, Korea, Republic of
19
Kyunggi-do, Korea, Republic of
8
Pusan, Korea, Republic of
11
Seongnam-si, Korea, Republic of
17
Seoul, Korea, Republic of
2
Seoul, Korea, Republic of
1
Seoul, Korea, Republic of
3
Seoul, Korea, Republic of
4
Seoul, Korea, Republic of
18
Seoul, Korea, Republic of
6
Seoul, Korea, Republic of
16
Seoul, Korea, Republic of
5
Seoul, Korea, Republic of
22
Ulsan, Korea, Republic of
Sponsors and Collaborators
UCB Korea Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center 1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB Korea Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01229735     History of Changes
Other Study ID Numbers: N01353
Study First Received: October 26, 2010
Last Updated: August 29, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by UCB Pharma:
levetiracetam
topiramate
epilepsy
partial seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014