An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

NCT ID: NCT01506882

Last Updated: 2015-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Epilepsy; Partial Onset Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam 1000 mg/day to 2000 mg/day group

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.

Group Type: EXPERIMENTAL

Levetiracetam (LEV)

Intervention Type: DRUG

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

Levetiracetam 3000 mg/day group

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.

Group Type: EXPERIMENTAL

Levetiracetam (LEV)

Intervention Type: DRUG

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

Interventions

Levetiracetam (LEV)

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

Intervention Type: DRUG

Other Intervention Names

Keppra; E Keppra

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

19

Aomori, , Japan

33

Asaka, , Japan

21

Daitō, , Japan

12

Fujisawa, , Japan

14

Hamamatsu, , Japan

11

Himeji, , Japan

30

Hirosaki, , Japan

8

Kagoshima, , Japan

20

Kamakura, , Japan

17

Kawasaki, , Japan

3

Kitakyushu, , Japan

26

Kodaira, , Japan

9

Kokubunji, , Japan

32

Kyoto, , Japan

25

Miyakonojō, , Japan

5

Nagoya Aichi, , Japan

4

Nara, , Japan

22

Okayama, , Japan

15

Osaka, , Japan

27

Osaka, , Japan

13

Saitama, , Japan

1

Sakai, , Japan

29

Sapporo, , Japan

24

Sayama, , Japan

2

Toyonaka, , Japan

7

Ube, , Japan

18

Yamagata, , Japan

Countries

Japan

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2014-004377-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01375

Identifier Type: -

Identifier Source: org_study_id