A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
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
2 other identifiers
interventional
361
2 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
Typical duration for phase_3
58 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
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
May 13, 2015
CompletedApril 3, 2025
April 1, 2025
3.5 years
October 22, 2010
April 27, 2015
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)\*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
From Baseline to Week 28
Secondary Outcomes (4)
The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period
From Baseline to Evaluation Period (Week 12 to Week 28)
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
From Baseline to Week 28
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
From Baseline to Evaluation Period (Week 12 to Week 28)
Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
Evaluation Period (Week 12 to Week 28)
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching placebo for 28 weeks
Levetiracetam
EXPERIMENTALLevetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Interventions
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
1
Beijing, China
9
Beijing, China
12
Changchun, China
19
Chengdu, China
6
Chengdu, China
10
Chongqing, China
16
Guangzhou, China
5
Guangzhou, China
18
Harbin, China
13
Kunming, China
22
Nanjing, China
14
Qingdao, China
2
Shanghai, China
3
Shanghai, China
17
Shenyang, China
15
Taiyuan, China
8
Wuhan, China
20
Xi'an, China
7
Xi'an, China
152
Fujisawa, Japan
112
Fukuoka, Japan
113
Fukuoka, Japan
166
Fukuoka, Japan
187
Fukushima, Japan
124
Hamamatsu, Japan
175
Higashiosaka, Japan
162
Himeji, Japan
110
Hiroshima, Japan
177
Hiroshima, Japan
165
Iizuka, Japan
143
Kagoshima, Japan
156
Kagoshima, Japan
176
Kameda, Japan
150
Kashihara, Japan
153
Kashiwakazi, Japan
105
Kokubunji, Japan
172
Miyakonojō, Japan
179
Miyazaki, Japan
186
Miyazaki, Japan
189
Nagoya, Japan
106
Niigata, Japan
158
Okayama, Japan
157
Osaka, Japan
174
Osaka, Japan
130
Otaru, Japan
129
Ōsaka-sayama, Japan
170
Saito, Japan
147
Sakai, Japan
194
Sakai, Japan
117
Sapporo, Japan
131
Sapporo, Japan
304
Sapporo, Japan
103
Sendai, Japan
168
Shimajiri, Japan
138
Shimotsuke, Japan
121
Shizuoka, Japan
120
Tokyo, Japan
111
Ube, Japan
Related Publications (1)
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.
PMID: 30525116RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 26, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2014
Study Completion
May 1, 2014
Last Updated
April 3, 2025
Results First Posted
May 13, 2015
Record last verified: 2025-04