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Completed

NCT Number: NCT01063764

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

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).

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Partial Seizures Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

21, Chūō, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Keppra

Primary outcomes

  1. 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

    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.

  2. 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)

    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.

Secondary outcomes

  1. 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)

    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.

  2. 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))

    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.

  3. 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)

    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.

  4. 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))

    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.

  5. 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)

    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.

  6. 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))

    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.

  7. 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)

    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.

  8. 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)

    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.

  9. 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)

    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.

Sponsors and collaborators

Lead sponsor

UCB Japan Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Feb 5, 2010
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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