An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

NCT ID: NCT01063764

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-10-31

Brief Summary

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Detailed Description

Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Conditions

Epilepsy; Partial Seizures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

Open-label, single-arm

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.

Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.

Interventions

Levetiracetam

First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.

Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.

Intervention Type: DRUG

Other Intervention Names

Keppra

Eligibility Criteria

Inclusion Criteria

• The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
• The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
• Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion Criteria

• The patient has a treatable seizure etiology
• The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
• The patient has a history of status Epilepticus during the 3 months prior to Visit 1
• The patient has a past and present history of pseudo seizures
• The patient has a current diagnosis of Lennox-Gastaut syndrome

• Minimum Eligible Age: 4 Years
• Maximum 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

21

Chūō, , Japan

12

Hakodate, , Japan

22

Hamamatsu, , Japan

28

Hiroshima, , Japan

7

Izumi, , Japan

9

Kobe, , Japan

3

Kodaira, , Japan

30

Koga, , Japan

10

Kōshi, , Japan

31

Kurume, , Japan

23

Kyoto, , Japan

2

Nagaoka, , Japan

5

Nagoya, , Japan

6

Nagoya, , Japan

8

Neyagawa, , Japan

1

Niigata, , Japan

27

Okayama, , Japan

24

Osaka, , Japan

25

Osaka, , Japan

11

Sapporo, , Japan

13

Sendai, , Japan

4

Shizuoka, , Japan

26

Takatsuki, , Japan

16

Tokyo, , Japan

17

Tokyo, , Japan

15

Yachiyo, , Japan

14

Yamagata, , Japan

19

Yokohama, , Japan

20

Yokohama, , Japan

Countries

Japan

References

Nakamura H, Osawa M, Yokoyama T, Yoshida K, Suzuki A. [Efficacy and safety of levetiracetam as adjunctive therapy in Japanese children with uncontrolled partial-onset seizures: multicenter and open-label study (N01223), short term evaluation]. Brain Nerve. 2013 Sep;65(9):1083-92. Japanese.

Reference Type: RESULT

PMID: 24018745 (View on PubMed)

Related Links

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

FDA Safety Alerts and Recalls

Other Identifiers

2014-004335-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01223

Identifier Type: -

Identifier Source: org_study_id