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Trial record 1 of 1 for:    NCT00160654
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Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160654
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE February 8, 2018
Results First Posted Date  ICMJE August 19, 2020
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE November 24, 2003
Actual Primary Completion Date December 12, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To assess safety of levetiracetam
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To evaluate efficacy of levetiracetam in community based practice.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Official Title  ICMJE 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.
Brief Summary

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

The optimal dose in daily clinical practice will be used.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, Partial
Intervention  ICMJE Drug: Levetiracetam
  • Pharmaceutical form: oral tablets
  • Concentration: 500 mg
  • Route of administration: Oral use
Other Name: Keppra
Study Arms  ICMJE Experimental: Levetiracetam
Subjects received open-label Levetiracetam.
Intervention: Drug: Levetiracetam
Publications * Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, Tonner F, Beh K, Edrich P; N01036 (SKATE II) Investigator Group. Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study. Epilepsy Behav. 2010 May;18(1-2):100-5. doi: 10.1016/j.yebeh.2010.03.016. Epub 2010 May 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2020)
251
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
345
Actual Study Completion Date  ICMJE December 12, 2006
Actual Primary Completion Date December 12, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00160654
Other Study ID Numbers  ICMJE N01036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares UCB (+1 844 599 2273)
PRS Account UCB Pharma
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP