NCT01506882

Brief Summary

The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Typical duration for phase_3

Geographic Reach
1 country

27 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

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 13, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

January 5, 2012

Results QC Date

October 7, 2014

Last Update Submit

November 24, 2015

Conditions

EpilepsyPartial Onset Seizures

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period

    A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free: * A documented seizure during 6 consecutive months of the Evaluation Analysis Period * Subject discontinued the study prematurely during the Evaluation Analysis Period * Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.

    From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

Secondary Outcomes (7)

  • Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period

    From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

  • Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period

    From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

  • Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period

    From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

  • Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

    During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

  • Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

    During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

  • +2 more secondary outcomes

Study Arms (2)

Levetiracetam 1000 mg/day to 2000 mg/day group

EXPERIMENTAL

Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.

Drug: Levetiracetam (LEV)

Levetiracetam 3000 mg/day group

EXPERIMENTAL

Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period. They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.

Drug: Levetiracetam (LEV)

Interventions

Levetiracetam (LEV)DRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: LEV 250 mg, LEV 500 mg * Frequency: Twice daily * Route of Administration: Oral use

Also known as: Keppra, E Keppra
Levetiracetam 1000 mg/day to 2000 mg/day groupLevetiracetam 3000 mg/day group

Eligibility Criteria

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

You may qualify if:

  • Subject is male or female and aged ≥ 16 years at Visit 1
  • Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
  • Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
  • Minimum body weight of 40 kg at Visit 1

You may not qualify if:

  • Subject has a history or presence of seizure types other than partial (IA, IB, IC)
  • Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
  • Subject has a history or presence of known Pseudo-Seizures
  • Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
  • Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

19

Aomori, Japan

Location

33

Asaka, Japan

Location

21

Daitō, Japan

Location

12

Fujisawa, Japan

Location

14

Hamamatsu, Japan

Location

11

Himeji, Japan

Location

30

Hirosaki, Japan

Location

8

Kagoshima, Japan

Location

20

Kamakura, Japan

Location

17

Kawasaki, Japan

Location

3

Kitakyushu, Japan

Location

26

Kodaira, Japan

Location

9

Kokubunji, Japan

Location

32

Kyoto, Japan

Location

25

Miyakonojō, Japan

Location

5

Nagoya Aichi, Japan

Location

4

Nara, Japan

Location

22

Okayama, Japan

Location

15

Osaka, Japan

Location

27

Osaka, Japan

Location

13

Saitama, Japan

Location

1

Sakai, Japan

Location

29

Sapporo, Japan

Location

24

Sayama, Japan

Location

2

Toyonaka, Japan

Location

7

Ube, Japan

Location

18

Yamagata, Japan

Location

Related Links

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
+1 877 822 9493

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 10, 2012

Study Start

December 1, 2011

Primary Completion

October 1, 2013

Study Completion

April 1, 2015

Last Updated

December 31, 2015

Results First Posted

October 13, 2014

Record last verified: 2015-11

Locations

JP(27)