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OpenTrials
Completed

NCT Number: NCT00160615

Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

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Key information

Conditions

Epilepsy, Partial Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

16 year and older

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

  • Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
  • Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion criteria

  • Patients who had not participate in N165 Clinical Trial of L059.
  • Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
  • Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Treatment and study plan

Levetiracetam

Drug
  • Pharmaceutical form: Film-coating tablets
  • Concentration: 250 mg/ 500 mg
  • Route of administration: oral use

Other names: Keppra

Primary outcomes

  1. Partial (Type I) Seizure Frequency Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

  2. Partial (Type IA) Seizure Frequency Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

  3. Partial (Type IB) Seizure Frequency Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

  4. Partial (Type IC) Seizure Frequency Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

Secondary outcomes

  1. Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.

  2. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.

  3. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.

  4. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit

    Time frame: From Baseline up to 54 months

    Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.

Sponsors and collaborators

Lead sponsor

UCB Japan Co. Ltd.

Industry

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jun 10, 2019

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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