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

Sponsors

Lead Sponsor: UCB Japan Co. Ltd.

Source UCB Pharma
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.

Overall Status Completed
Start Date October 2010
Completion Date May 2014
Primary Completion Date April 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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) From Baseline to Week 28
Secondary Outcome
Measure Time Frame
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)
Enrollment 361
Condition
Intervention

Intervention Type: Drug

Intervention Name: Levetiracetam

Description: Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks

Arm Group Label: Levetiracetam

Other Name: Keppra®

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching oral placebo tablets twice daily for 28 weeks

Arm Group Label: Placebo

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

Gender: All

Minimum Age: 16 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)
Location
Facility:
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
7 | Xi'an, China
20 | Xian, 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 | Miyakonojo, Japan
179 | Miyazaki, Japan
186 | Miyazaki, Japan
189 | Nagoya, Japan
106 | Niigata, Japan
158 | Okayama, Japan
129 | Osaka-sayama, Japan
157 | Osaka, Japan
174 | Osaka, Japan
130 | Otaru, 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
Location Countries

China

Japan

Verification Date

December 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Matching placebo for 28 weeks

Label: Levetiracetam

Type: Experimental

Description: Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov