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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229735
• Other study ID #: N01353
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2010
• Last updated: January 13, 2016
• Start date: November 2010
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• 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. 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)

Study Design

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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
• Topiramate
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks

Locations

Country	Name	City	State
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	1	Seoul
Korea, Republic of	16	Seoul
Korea, Republic of	17	Seoul
Korea, Republic of	18	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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		From Baseline to Week 52	No
Secondary	Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52		From Baseline to Week 52	No
Secondary	Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)		From Baseline to Week 52	No
Secondary	Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period 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.	From Baseline to Week 52	No
Secondary	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		From Baseline to Week 52	No