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OpenTrials
Completed

NCT Number: NCT00160654

Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

N01036 808, Hong Kong

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
  • Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
  • Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.

Exclusion criteria

  • Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
  • Presence of known pseudoseizures within the last year.
  • Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
  • Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Treatment and study plan

Levetiracetam

Drug
  • Pharmaceutical form: oral tablets
  • Concentration: 500 mg
  • Route of administration: Oral use

Other names: Keppra

Primary outcomes

  1. Number of Patients With Adverse Events (AEs)

    Time frame: From Baseline until Safety visit (two weeks after last dose; up to Week 18)

    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period

    Time frame: Week 16, compared to Baseline

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

    Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.

    A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline.

  2. Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period

    Time frame: Week 16, compared to Baseline

    Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period.

    Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.

    A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline.

  3. Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16

    Time frame: Week 16, compared to Baseline

    50% response in seizure frequency per Week is defined as >=50% reduction in seizure frequency from Baseline.

    Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.

  4. Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16

    Time frame: Week 16, compared to Baseline

    100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline.

    Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.

  5. Percentage of Patients With Categorized Change From Baseline in Severity of Illness

    Time frame: Baseline, Week 16

    The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening.

  6. Retention Rate at Week 16

    Time frame: Week 16

    Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase IV, Open-label, Multi-center, Community-based Trial in Asia Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Aug 19, 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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