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

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.

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

The optimal dose in daily clinical practice will be used.

Study Overview

• Status: Completed
• Conditions: Epilepsy, Partial
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • N01036 808
  • Hong Kong, Hong Kong
    • N01036 842
  • Kwun Tong, Hong Kong
    • N01036 815
• Malaysia
  • Kuala Lumpur, Malaysia
    • N01036 811
  • Kuala Lumpur, Malaysia
    • N01036 812
  • Kuala Lumpur, Malaysia
    • N01036 813
• Philippines
  • Manila, Philippines
    • N01036 830
  • Manila, Philippines
    • N01036 831
  • Quezon, Philippines
    • N01036 829
• Singapore
  • Singapore, Singapore
    • N01036 804
  • Singapore, Singapore
    • N01036 806
  • Singapore, Singapore
    • N01036 807
• Taiwan
  • Changhua, Taiwan
    • N01036 828
  • Hualien City, Taiwan
    • N01036 827
  • Kaohsiung, Taiwan
    • N01036 834
  • Kaohsiung, Taiwan
    • N01036 835
  • Kaohsiung City, Taiwan
    • N01036 825
  • Taichung, Taiwan
    • N01036 817
  • Taichung city, Taiwan
    • N01036 823
  • Tainan, Taiwan
    • N01036 818
  • Taipei, Taiwan
    • N01036 819
  • Taipei, Taiwan
    • N01036 820
  • Taipei, Taiwan
    • N01036 821
  • Taoyuan, Taiwan
    • N01036 822
• Thailand
  • Bangkok, Thailand
    • N01036 809
  • Bangkok, Thailand
    • N01036 840
  • Bangkok, Thailand
    • N01036 841
  • Chiang Mai, Thailand
    • N01036 839
  • Khon Kaen, Thailand
    • N01036 810

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Levetiracetam; Subjects received open-label Levetiracetam.	Drug: Levetiracetam; Pharmaceutical form: oral tablets; Concentration: 500 mg; Route of administration: Oral use; Other Names: Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Adverse Events (AEs)	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.	From Baseline until Safety visit (two weeks after last dose; up to Week 18)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period	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.	Week 16, compared to Baseline
Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period	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.	Week 16, compared to Baseline
Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16	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.	Week 16, compared to Baseline
Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16	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.	Week 16, compared to Baseline
Percentage of Patients With Categorized Change From Baseline in Severity of Illness	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.	Baseline, Week 16
Retention Rate at 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.	Week 16

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 24, 2003
• Primary Completion (ACTUAL): December 12, 2006
• Study Completion (ACTUAL): December 12, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (ESTIMATE): September 12, 2005

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Epilepsy; Partial Onset Seizures; Levetiracetam; Keppra
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01036

Drug and device information, study documents

• 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