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

• ClinicalTrials.gov Identifier: NCT01229735
• Recruitment Status: Completed
• First Posted: October 28, 2010
• Results First Posted: February 12, 2016
• Last Update Posted: August 15, 2017
• Sponsor: UCB Korea Co., Ltd.
• Information provided by (Responsible Party): UCB Pharma ( UCB Korea Co., Ltd. )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Epilepsy	Drug: Levetiracetam; Drug: Topiramate	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 343 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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 Subjects With Refractory Partial Onset Seizures
• Study Start Date: November 2010
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Levetiracetam; 250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 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; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE) [ Time Frame: From Baseline to Week 52 ]
3. Median 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 ]
   Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
4. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Korea, Republic of

14

Busan, Korea, Republic of

21

Busan, Korea, Republic of

8

Busan, Korea, Republic of

9

Busan, Korea, Republic of

12

Daegu, Korea, Republic of

13

Daegu, Korea, Republic of

10

Daejeon, Korea, Republic of

25

Daejeon, Korea, Republic of

15

Gwangju, Korea, Republic of

7

Incheon, Korea, Republic of

11

Kyunggi-Do, Korea, Republic of

19

Kyunggi-do, Korea, Republic of

23

Kyunggi-Do, Korea, Republic of

24

Kyunggi-Do, Korea, Republic of

16

Seoul, Korea, Republic of

17

Seoul, Korea, Republic of

18

Seoul, Korea, Republic of

1

Seoul, Korea, Republic of

2

Seoul, Korea, Republic of

3

Seoul, Korea, Republic of

4

Seoul, Korea, Republic of

5

Seoul, Korea, Republic of

6

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

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Korea Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01229735
• Other Study ID Numbers: N01353
• First Posted: October 28, 2010
• Results First Posted: February 12, 2016
• Last Update Posted: August 15, 2017
• Last Verified: July 2017

Keywords provided by UCB Pharma ( UCB Korea Co., Ltd. ):

levetiracetam; topiramate; epilepsy; partial seizures

Additional relevant MeSH terms:

Epilepsy; Seizures; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Topiramate; Levetiracetam; Anticonvulsants; Hypoglycemic Agents; Physiological Effects of Drugs; Nootropic Agents