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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004401-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo for 28 weeks |
|
| Levetiracetam | Experimental | Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks |
|
| Measure | Description | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period | Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation 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. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 | Beijing | China | ||||
| 9 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30525116 | Result | 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. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set consisting of all screened subjects who signed the Informed Consent form, participated in the prospective Baseline Period and were randomized at Visit 2.
This study started to enroll subjects in Japan and China in October 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo for 28 weeks Placebo: Matching oral placebo tablets twice daily for 28 weeks |
| FG001 | Levetiracetam | Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks Levetiracetam: Oral dose tablets, twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching oral placebo tablets twice daily for 28 weeks |
|
| 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 | A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline | 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 | A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline | From Baseline to Evaluation Period (Week 12 to Week 28) |
| Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period. | Evaluation Period (Week 12 to Week 28) |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Placebo or Levetiracetam.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo for 28 weeks Placebo: Matching oral placebo tablets twice daily |
| BG001 | Levetiracetam | Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks Levetiracetam: Oral dose tablets, twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline. | Posted | Mean | Standard Deviation | Percentage Change | From Baseline to Week 28 |
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| Secondary | The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period | Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation 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. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline. | Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure in Evaluation Period. | Posted | Mean | Standard Deviation | Percentage Change | From Baseline to Evaluation Period (Week 12 to Week 28) |
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| Secondary | 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 | A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline | Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline. | Posted | Number | participants | From Baseline to Week 28 |
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| Secondary | 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 | A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder. Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline | Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure. | Posted | Number | participants | From Baseline to Evaluation Period (Week 12 to Week 28) |
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| Secondary | Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period. | Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure. | Posted | Number | participants | Evaluation Period (Week 12 to Week 28) |
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Adverse Events were collected from the Prospective Baseline Period ( Week -8 to Week 0) over Dose Adjustment (12 weeks) and Evaluation Period (16 weeks) until Conversion or Withdrawal Period (4-6 weeks).
Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Placebo or Levetiracetam.
Adverse Events were presented for the Dose Adjustment and Evaluation Period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo for 28 weeks Placebo: Matching oral placebo tablets twice daily for 28 weeks | 4 | 125 | 32 | 125 | ||
| EG001 | Levetiracetam | Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks Levetiracetam: Oral dose tablets, twice daily | 1 | 126 | 40 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowning | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Sudden unexplained death in epilepsy | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA (17.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| Japan |
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| Superiority or Other (legacy) |
| Units | Counts |
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