Clinical trial NCT00280696: A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
Official title: A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies, Partial
Keywords: Epilepsies, Partial,
Keppra, levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 352
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.


Eligibility criteria: Inclusion Criteria:

Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:

* Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
* Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
* Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
* Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks

Exclusion Criteria:

The following patients are not eligible for inclusion into the study:

* Subjects who were diagnosed with status epilepticus within 3 months before screening
* Subjects with no partial seizures of which frequency was measured during the Baseline Period
* Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
* Subjects with a history of oral treatment with Levetiracetam (LEV)

Primary outcomes:
measure: Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
timeFrame: From Baseline to the 12-week Evaluation Period
Secondary outcomes:
measure: Partial (Type I) seizure frequency per week over the Evaluation Period
timeFrame: 12-week Evaluation Period
measure: Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period
timeFrame: From Baseline to the 12-week Evaluation Period
measure: Seizure freedom over the Evaluation Period
timeFrame: 12-week Evaluation Period
measure: Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
timeFrame: From Baseline to the 12-week Evaluation Period
measure: Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period
timeFrame: From Baseline to the 12-week Evaluation Period
Other outcomes:
Locations:
city: Aichi-gun
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nayoga
country: Japan
state: Aichi
city: Hirosaki
country: Japan
state: Aomori
city: Kitakyusyu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Fukuyama
country: Japan
state: Hiroshima
city: Asahikawa
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Kahoku-gun
country: Japan
state: Ishikawa
city: Kikuchi-gun
country: Japan
state: Kumamoto
city: Sendai
country: Japan
state: Miyagi
city: Omura
country: Japan
state: Nagasaki
city: Izumi
country: Japan
state: Osaka
city: Neyagawa
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Kawachi-gun
country: Japan
state: Tochigi
city: Kodaira
country: Japan
state: Tokyo
city: Ube
country: Japan
state: Yamaguchi
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Gihu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kobe
country: Japan
city: Kyoto
country: Japan
city: Miyazaki
country: Japan
city: Nagaoka
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
city: Tokyo
country: Japan
city: Toyama
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13.