Clinical trial NCT00160654: Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy, Partial
Keywords: Epilepsy
Partial Onset Seizures
Keppra
Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: From Baseline until Safety visit (two weeks after last dose; up to Week 18)
Secondary outcomes:
measure: Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period
timeFrame: Week 16, compared to Baseline
measure: Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period
timeFrame: Week 16, compared to Baseline
measure: Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16
timeFrame: Week 16, compared to Baseline
measure: Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16
timeFrame: Week 16, compared to Baseline
measure: Percentage of Patients With Categorized Change From Baseline in Severity of Illness
timeFrame: Baseline, Week 16
measure: Retention Rate at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: N01036 808
city: Hong Kong
country: Hong Kong
facility: N01036 842
city: Kwun Tong
country: Hong Kong
facility: N01036 815
city: Kuala Lumpur
country: Malaysia
facility: N01036 811
city: Kuala Lumpur
country: Malaysia
facility: N01036 812
city: Kuala Lumpur
country: Malaysia
facility: N01036 813
city: Manila
country: Philippines
facility: N01036 830
city: Manila
country: Philippines
facility: N01036 831
city: Quezon
country: Philippines
facility: N01036 829
city: Singapore
country: Singapore
facility: N01036 804
city: Singapore
country: Singapore
facility: N01036 806
city: Singapore
country: Singapore
facility: N01036 807
city: Changhua
country: Taiwan
facility: N01036 828
city: Hualien City
country: Taiwan
facility: N01036 827
city: Kaohsiung City
country: Taiwan
facility: N01036 825
city: Kaohsiung
country: Taiwan
facility: N01036 834
city: Kaohsiung
country: Taiwan
facility: N01036 835
city: Taichung city
country: Taiwan
facility: N01036 823
city: Taichung
country: Taiwan
facility: N01036 817
city: Tainan
country: Taiwan
facility: N01036 818
city: Taipei
country: Taiwan
facility: N01036 819
city: Taipei
country: Taiwan
facility: N01036 820
city: Taipei
country: Taiwan
facility: N01036 821
city: Taoyuan
country: Taiwan
facility: N01036 822
city: Bangkok
country: Thailand
facility: N01036 809
city: Bangkok
country: Thailand
facility: N01036 840
city: Bangkok
country: Thailand
facility: N01036 841
city: Chiang Mai
country: Thailand
facility: N01036 839
city: Khon Kaen
country: Thailand
facility: N01036 810
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.