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.
1 other identifier
interventional
251
6 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2003
Typical duration for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2006
CompletedResults Posted
Study results publicly available
August 19, 2020
CompletedAugust 19, 2020
August 1, 2020
3.1 years
September 8, 2005
February 8, 2018
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period
Week 16, compared to Baseline
Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period
Week 16, compared to Baseline
Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16
Week 16, compared to Baseline
Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16
Week 16, compared to Baseline
Percentage of Patients With Categorized Change From Baseline in Severity of Illness
Baseline, Week 16
- +1 more secondary outcomes
Study Arms (1)
Levetiracetam
EXPERIMENTALSubjects received open-label Levetiracetam.
Interventions
* Pharmaceutical form: oral tablets * Concentration: 500 mg * Route of administration: Oral use
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (29)
N01036 808
Hong Kong, Hong Kong
N01036 842
Hong Kong, Hong Kong
N01036 815
Kwun Tong, Hong Kong
N01036 811
Kuala Lumpur, Malaysia
N01036 812
Kuala Lumpur, Malaysia
N01036 813
Kuala Lumpur, Malaysia
N01036 830
Manila, Philippines
N01036 831
Manila, Philippines
N01036 829
Quezon, Philippines
N01036 804
Singapore, Singapore
N01036 806
Singapore, Singapore
N01036 807
Singapore, Singapore
N01036 828
Changhua, Taiwan
N01036 827
Hualien City, Taiwan
N01036 825
Kaohsiung City, Taiwan
N01036 834
Kaohsiung City, Taiwan
N01036 835
Kaohsiung City, Taiwan
N01036 817
Taichung, Taiwan
N01036 823
Taichung, Taiwan
N01036 818
Tainan, Taiwan
N01036 819
Taipei, Taiwan
N01036 820
Taipei, Taiwan
N01036 821
Taipei, Taiwan
N01036 822
Taoyuan District, Taiwan
N01036 809
Bangkok, Thailand
N01036 840
Bangkok, Thailand
N01036 841
Bangkok, Thailand
N01036 839
Chiang Mai, Thailand
N01036 810
Khon Kaen, Thailand
Related Publications (1)
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.
PMID: 20462804RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
UCB (+1 844 599 2273)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
November 24, 2003
Primary Completion
December 12, 2006
Study Completion
December 12, 2006
Last Updated
August 19, 2020
Results First Posted
August 19, 2020
Record last verified: 2020-08