Clinical trial NCT01228747: A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
Official title: A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Generalized Tonic-Clonic Seizures
Keywords: Levetiracetam
epilepsy
generalized tonic-clonic
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-10-26
Enrollment: 361
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.


Eligibility criteria: Inclusion Criteria:

* An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)
* A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period

Exclusion Criteria:

* Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
* Diagnosis of Lennox-Gastaut Syndrome
* Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features
* A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

Primary outcomes:
measure: Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)
timeFrame: From Baseline to Week 28
Secondary outcomes:
measure: The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period
timeFrame: From Baseline to Evaluation Period (Week 12 to Week 28)
measure: Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
timeFrame: From Baseline to Week 28
measure: Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period
timeFrame: From Baseline to Evaluation Period (Week 12 to Week 28)
measure: Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
timeFrame: Evaluation Period (Week 12 to Week 28)
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1
city: Beijing
country: China
facility: 9
city: Changchun
country: China
facility: 12
city: Chengdu
country: China
facility: 19
city: Chengdu
country: China
facility: 6
city: Chongqing
country: China
facility: 10
city: Guangzhou
country: China
facility: 16
city: Guangzhou
country: China
facility: 5
city: Harbin
country: China
facility: 18
city: Kunming
country: China
facility: 13
city: Nanjing
country: China
facility: 22
city: Qingdao
country: China
facility: 14
city: Shanghai
country: China
facility: 2
city: Shanghai
country: China
facility: 3
city: Shenyang
country: China
facility: 17
city: Taiyuan
country: China
facility: 15
city: Wuhan
country: China
facility: 8
city: Xi'an
country: China
facility: 7
city: Xian
country: China
facility: 20
city: Fujisawa
country: Japan
facility: 152
city: Fukuoka
country: Japan
facility: 112
city: Fukuoka
country: Japan
facility: 113
city: Fukuoka
country: Japan
facility: 166
city: Fukushima
country: Japan
facility: 187
city: Hamamatsu
country: Japan
facility: 124
city: Higashiosaka
country: Japan
facility: 175
city: Himeji
country: Japan
facility: 162
city: Hiroshima
country: Japan
facility: 110
city: Hiroshima
country: Japan
facility: 177
city: Iizuka
country: Japan
facility: 165
city: Kagoshima
country: Japan
facility: 143
city: Kagoshima
country: Japan
facility: 156
city: Kameda
country: Japan
facility: 176
city: Kashihara
country: Japan
facility: 150
city: Kashiwakazi
country: Japan
facility: 153
city: Kokubunji
country: Japan
facility: 105
city: Miyakonojo
country: Japan
facility: 172
city: Miyazaki
country: Japan
facility: 179
city: Miyazaki
country: Japan
facility: 186
city: Nagoya
country: Japan
facility: 189
city: Niigata
country: Japan
facility: 106
city: Okayama
country: Japan
facility: 158
city: Osaka-sayama
country: Japan
facility: 129
city: Osaka
country: Japan
facility: 157
city: Osaka
country: Japan
facility: 174
city: Otaru
country: Japan
facility: 130
city: Saito
country: Japan
facility: 170
city: Sakai
country: Japan
facility: 147
city: Sakai
country: Japan
facility: 194
city: Sapporo
country: Japan
facility: 117
city: Sapporo
country: Japan
facility: 131
city: Sapporo
country: Japan
facility: 304
city: Sendai
country: Japan
facility: 103
city: Shimajiri
country: Japan
facility: 168
city: Shimotsuke
country: Japan
facility: 138
city: Shizuoka
country: Japan
facility: 121
city: Tokyo
country: Japan
facility: 120
city: Ube
country: Japan
facility: 111
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Wu L, Yagi K, Hong Z, Liao W, Wang X, Zhou D, Inoue Y, Ohtsuka Y, Sasagawa M, Terada K, Du X, Muramoto Y, Sano T. Adjunctive levetiracetam in the treatment of Chinese and Japanese adults with generalized tonic-clonic seizures: A double-blind, randomized, placebo-controlled trial. Epilepsia Open. 2018 Sep 29;3(4):474-484. doi: 10.1002/epi4.12255. eCollection 2018 Dec.