NCT01229735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 12, 2016

Completed
Last Updated

August 15, 2017

Status Verified

July 1, 2017

Enrollment Period

4.5 years

First QC Date

October 26, 2010

Results QC Date

November 9, 2015

Last Update Submit

July 6, 2017

Conditions

Epilepsy

Keywords

levetiracetamtopiramateepilepsypartial seizures

Outcome Measures

Primary Outcomes (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

    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

    From Baseline to Week 52

  • Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)

    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

    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

    From Baseline to Week 52

Study Arms (2)

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

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

Drug: Topiramate

Interventions

LevetiracetamDRUG

250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks

Also known as: Keppra
Levetiracetam
TopiramateDRUG

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

Topiramate

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

14

Busan, South Korea

Location

21

Busan, South Korea

Location

8

Busan, South Korea

Location

9

Busan, South Korea

Location

12

Daegu, South Korea

Location

13

Daegu, South Korea

Location

10

Daejeon, South Korea

Location

25

Daejeon, South Korea

Location

15

Gwangju, South Korea

Location

7

Incheon, South Korea

Location

11

Kyunggi-Do, South Korea

Location

19

Kyunggi-do, South Korea

Location

23

Kyunggi-Do, South Korea

Location

24

Kyunggi-Do, South Korea

Location

16

Seoul, South Korea

Location

17

Seoul, South Korea

Location

18

Seoul, South Korea

Location

1

Seoul, South Korea

Location

2

Seoul, South Korea

Location

3

Seoul, South Korea

Location

4

Seoul, South Korea

Location

5

Seoul, South Korea

Location

6

Seoul, South Korea

Location

22

Ulsan, South Korea

Location

Related Links

MeSH Terms

Conditions

EpilepsySeizures

Interventions

LevetiracetamTopiramate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB Pharma
+1877 822

Study Officials

  • UCB Clinical Trial Call Center

    1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2010

First Posted

October 28, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 15, 2017

Results First Posted

February 12, 2016

Record last verified: 2017-07

Locations

KR(24)