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Completed

NCT Number: NCT01506882

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Partial Onset Seizures

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

19, Aomori, Japan

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Levetiracetam (LEV)

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

Other names: Keppra, E Keppra

Primary outcomes

  1. Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period

    Time frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

    A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:

    • A documented seizure during 6 consecutive months of the Evaluation Analysis Period
    • Subject discontinued the study prematurely during the Evaluation Analysis Period
    • Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.

Secondary outcomes

  1. Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period

    Time frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

    Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.

  2. Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period

    Time frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

    A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:

    • A documented seizure during 6 consecutive months of the Evaluation Analysis Period
    • Subject discontinued the study prematurely during the Evaluation Analysis Period
    • Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.

  3. Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period

    Time frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

    Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.

  4. Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

    Time frame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

    Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.

    The Median time to first seizure will be estimated from the Kaplan-Meier curve.

  5. Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

    Time frame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

    Median time to withdrawal will be estimated from the Kaplan-Meier curve.

  6. Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group

    Time frame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

    Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.

    The Median time to first seizure will be estimated from the Kaplan-Meier curve.

  7. Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group

    Time frame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

    Median time to withdrawal will be estimated from the Kaplan-Meier curve.

Sponsors and collaborators

Lead sponsor

UCB Japan Co. Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Jan 10, 2012
Registry last updated
Dec 31, 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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