EpilepsyPhase 4NCT01229735

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

A Phase 4 study testing Levetiracetam and Topiramate in people with Epilepsy, run by UCB Korea Co., Ltd. at 24 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 16 to 80 years
Conditions the study is for: Epilepsy
What is being tested?: Levetiracetam and Topiramate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 24 sitesSouth Korea
Study dates: Nov 2010to May 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

South Korea24 sites

14
Busan
21
Busan
8
Busan
9
Busan
12
Daegu
13
Daegu
10
Daejeon
25
Daejeon
15
Gwangju
7
Incheon
19
Kyunggi-do
11
Kyunggi-Do
23
Kyunggi-Do
24
Kyunggi-Do
16
Seoul
17
Seoul
18
Seoul
1
Seoul
2
Seoul
3
Seoul
4
Seoul
5
Seoul
6
Seoul
22
Ulsan

Other trials in South Korea

About this study

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

Conditions: Epilepsy
Being tested: Levetiracetam, Topiramate
Keywords: levetiracetam, topiramate, epilepsy, partial seizures
Medical subject headings: Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevetiracetamDrug
Also called Keppra
250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
TopiramateDrug
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks

Study groups in NCT01229735
Study group	Role	What they receive
Levetiracetam	Experimental	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 Receives: Drug: Levetiracetam
Topiramate	Active comparator	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 Receives: Drug: Topiramate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From Baseline to Week 52

Secondary outcomes (4)

Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
Measured: From Baseline to Week 52
Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Measured: From Baseline to Week 52
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.
Measured: 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
Measured: From Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2015

First posted28 Oct 2010 (estimated)
Study startNov 2010
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01229735
Sponsor's protocol ID: N01353
Status last verified: Jul 2017
First submitted: 26 Oct 2010
Last updated: 15 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01229735
Acronym / sponsor ID: N01353
Conditions: Epilepsy
Keywords: levetiracetam, topiramate, epilepsy, partial seizures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: UCB Korea Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 28 Oct 2010 (estimated)
Results: Posted 12 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levetiracetam	Experimental	Drug: Levetiracetam250 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
Topiramate	Active comparator	Drug: Topiramate25 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

Who may qualify

Ages: 16 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LevetiracetamAlso: Keppra250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks	Drug	Levetiracetam
Topiramate25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks	Drug	Topiramate

Primary outcome

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

4 secondary outcomes

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
Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Time frame: From Baseline to Week 52
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
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

Results and safety

Results posted to the registry on 12 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levetiracetam	177	111
Topiramate	166	100

Primary outcome: 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. Number. Unit: percentage of subjects

Measure	Levetiracetam (Full Analysis Set) n = 176	Topiramate (Full Analysis Set) n = 166
Value	59.1	56.6

Levetiracetam (Full Analysis Set) vs Topiramate (Full Analysis Set): Odds Ratio (OR): 1.1 (95% CI 0.7 to 1.7), p =0.7007, Regression, Logistic

Population analysed: The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levetiracetam	10 of 177 (5.6%)	86 of 177 (48.6%)	Not reported
Topiramate	15 of 166 (9%)	91 of 166 (54.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

1 877 822 9493 (UCB)

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levetiracetam and Topiramate in people with Epilepsy, run by UCB Korea Co., Ltd. at 24 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01229735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.