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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01063764
First received: February 1, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Epilepsy
Partial Seizures
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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.

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted) [ Time Frame: 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) ] [ Designated as safety issue: No ]

    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 number of subjects with at least one treatment-emergent AE.

    The data provided here are interim results up to June the 14th 2011 and will only show a part of the Second Period. The results may change prior to final lock of study database, because this study is already ongoing.



Secondary Outcome Measures:
  • Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period [ Time Frame: From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) ] [ Designated as safety issue: No ]

    The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:

    (B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation 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.

  • Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period [ Time Frame: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)) ] [ Designated as safety issue: No ]

    The seizure frequency per week was calculated as:

    Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  • Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period [ Time Frame: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) ] [ Designated as safety issue: No ]

    The seizure frequency per week was calculated as:

    Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  • Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period [ Time Frame: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)) ] [ Designated as safety issue: No ]

    50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.

    Partial seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  • Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period [ Time Frame: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) ] [ Designated as safety issue: No ]

    50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.

    Partial seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  • Number of Seizure-free Subjects Over the 14-weeks Treatment Period [ Time Frame: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)) ] [ Designated as safety issue: No ]

    Seizure-free means not having a seizure of type I (Partial seizure).

    Partial seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  • Number of Seizure-free Subjects Over the 10-weeks Evaluation Period [ Time Frame: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) ] [ Designated as safety issue: No ]

    Seizure-free means not having a seizure of type I (Partial seizure).

    Partial seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to secondarily generalized seizures.

  • Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted) [ Time Frame: 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) ] [ Designated as safety issue: No ]

    An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.

    The data provided here are interim results up to June the 14th 2011 and will only show a part of the Second Period. The results may change prior to final lock of study database, because this study is already ongoing.


  • Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted) [ Time Frame: From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period) ] [ Designated as safety issue: No ]

    The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers)is presented.

    Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:

    (B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.



Enrollment: 73
Study Start Date: January 2010
Study Completion Date: October 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Open-label, single-arm
Drug: 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.

Other Name: Keppra

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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063764

Locations
Japan
21
Chuo, Japan
12
Hakodate, Japan
22
Hamamatsu, Japan
28
Hiroshima, Japan
7
Izumi, Japan
9
Kobe, Japan
3
Kodaira, Japan
30
Koga, Japan
10
Koushi, 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
25
Osaka, Japan
24
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
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01063764     History of Changes
Other Study ID Numbers: N01223
Study First Received: February 1, 2010
Results First Received: March 28, 2012
Last Updated: October 30, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Keppra
Levetiracetam
Children
Epilepsy
Partial Seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014