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

NCT01063764 | Completed Phase 3 Results

• 2 other identifiers: N012232014-004335-39
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 29

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).

Conditions

Epilepsy; Partial Seizures

Keywords

Keppra; Levetiracetam; Children; Epilepsy; Partial Seizures

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period

  The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as: (B values- T values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

  From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22

• Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)

  An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.

  During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)

Secondary Outcomes (9)

• Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period

  From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

• Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period

  14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))

• Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period

  10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

• Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period

  14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))

• Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period

  10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Open-label, single-arm

Drug: Levetiracetam

Interventions

Levetiracetam 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.

Also known as: Keppra

Levetiracetam

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead

Study Sites (29)

21

Chūō, Japan

Location

12

Hakodate, Japan

Location

22

Hamamatsu, Japan

Location

28

Hiroshima, Japan

Location

7

Izumi, Japan

Location

9

Kobe, Japan

Location

3

Kodaira, Japan

Location

30

Koga, Japan

Location

10

Kōshi, Japan

Location

31

Kurume, Japan

Location

23

Kyoto, Japan

Location

2

Nagaoka, Japan

Location

5

Nagoya, Japan

Location

6

Nagoya, Japan

Location

8

Neyagawa, Japan

Location

1

Niigata, Japan

Location

27

Okayama, Japan

Location

24

Osaka, Japan

Location

25

Osaka, Japan

Location

11

Sapporo, Japan

Location

13

Sendai, Japan

Location

4

Shizuoka, Japan

Location

26

Takatsuki, Japan

Location

16

Tokyo, Japan

Location

17

Tokyo, Japan

Location

15

Yachiyo, Japan

Location

14

Yamagata, Japan

Location

19

Yokohama, Japan

Location

20

Yokohama, Japan

Location

Related Publications (1)

• 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.

  PMID: 24018745 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2013
• Last Updated: March 5, 2015
• Results First Posted: June 19, 2012

Record last verified: 2015-02

Locations

JP (29)