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Completed

NCT Number: NCT00150748

Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

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Key information

Conditions

Generalized Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Nervous System Diseases

Age range

4 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
  • Subjects who were/are suffering from primary generalized (type II) epileptic seizures
  • Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected

Exclusion criteria

  • Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
  • Concomitant use of any drug with possible central nervous system effects unless at a stable dose
  • Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time

Treatment and study plan

Levetiracetam 166 mg

Drug
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 166 mg
  • Route of Administration: Oral use

Levetiracetam 250 mg

Drug
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 250 mg
  • Route of Administration: Oral use

Levetiracetam 500 mg

Drug
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 500 mg
  • Route of Administration: Oral use

Primary outcomes

  1. Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

    Time frame: Evaluation Period

  2. Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

    Time frame: Evaluation Period

Secondary outcomes

  1. Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

    Time frame: From Visit 1 to the end of the Evaluation Period

  2. Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

    Time frame: From Visit 1 to the end of the Evaluation Period

  3. Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  4. Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  5. Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  6. Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  7. Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

    Time frame: Evaluation Period

  8. Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Time frame: Evaluation Period

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study title

An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 8, 2005
Registry last updated
Jul 29, 2020

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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