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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000897-21 | EudraCT Number |
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The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keppra XR 1000 mg/day | Experimental | 1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily) |
|
| Keppra XR 2000 mg/day | Experimental | 2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keppra XR | Drug | Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase | Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678. | 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase | The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dothan | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22516508 | Derived | Chung S, Ceja H, Gawlowicz J, Avakyan G, McShea C, Schiemann J, Lu S. Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study. Epilepsy Res. 2012 Aug;101(1-2):92-102. doi: 10.1016/j.eplepsyres.2012.03.007. Epub 2012 Apr 18. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Subjects are to be randomized into treatment with either Keppra XR 2000 mg/day or Keppra XR 1000 mg/day in a 3:1 ratio.
The Efficacy (EFF) population is defined as all subjects in the Intent to Treat (ITT) population who enter into the Previous Antiepileptic (AED) Discontinuation (D/C) Phase. The Per Protocol (PP) population consists of all subjects in the EFF population who have no important protocol deviations related to efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Keppra XR 1000 mg/Day | 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) |
| FG001 | Keppra XR 2000 mg/Day | 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Keppra XR | Drug | Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks |
|
| 112 days |
| The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase | The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112. | 112 days |
| The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase | Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112. | 112 days |
| Northport |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Little Rock | Arkansas | United States |
| Bakersfield | California | United States |
| Jacksonville | Florida | United States |
| Loxahatchee Groves | Florida | United States |
| Atlanta | Georgia | United States |
| Suwanee | Georgia | United States |
| Winfield | Illinois | United States |
| Witchita | Kansas | United States |
| Shreveport | Louisiana | United States |
| Bethesda | Maryland | United States |
| Detroit | Michigan | United States |
| Camden | New Jersey | United States |
| New Brunswick | New Jersey | United States |
| Buffalo | New York | United States |
| Cedarhurst | New York | United States |
| Toledo | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Bend | Oregon | United States |
| Monaca | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Beaufort | South Carolina | United States |
| Monterrey | Nuevo León | Mexico |
| Aguascalientes | Mexico |
| Distrio Federal | Mexico |
| Guadalajara | Mexico |
| Guadalajara Jalisco | Mexico |
| Mexico City | Mexico |
| Monterrey | Mexico |
| Bialystok | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Poznan | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Kalingrad | Russia |
| Kazan' | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Yaroslavl | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Keppra XR 1000 mg/Day | 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) |
| BG001 | Keppra XR 2000 mg/Day | 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase | Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678. | Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Primary Efficacy analysis was conducted for the Keppra XR 2000 mg/day group only. | Posted | Number | 95% Confidence Interval | proportion of subjects | 112 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase | The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112. | Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only. | Posted | Number | 95% Confidence Interval | proportion of subjects | 112 days |
| ||||||||||||||||||||||||||||||
| Secondary | The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase | The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112. | Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only. | Posted | Number | 95% Confidence Interval | proportion of subjects | 112 days |
|
| |||||||||||||||||||||||||||||
| Secondary | The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase | Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112. | Of the 57 (Keppra 1000 mg) subjects randomized, 54 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. | Posted | Number | 95% Confidence Interval | proportion of subjects | 112 days |
|
|
Up to 29 weeks
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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 | Keppra XR 1000 mg/Day | 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) | 2 | 57 | 33 | 57 | ||
| EG001 | Keppra XR 2000 mg/Day | 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily) | 12 | 171 | 87 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| pancreatitis acute | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| pulmonary tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| pyelonephritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| ankle fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| status epilepticus | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| acute psychosis | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vertigo | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| irritablility | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| somnolence | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB, Inc. | +1 877 822 9493 |
| 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 |
|
| Male |
|
| Mexico |
|
| Poland |
|
| Russian Federation |
|
| Units | Counts |
|---|---|
| Participants |
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| Participants |
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