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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000987-10 | EudraCT Number |
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This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keppra® XR | Experimental | Keppra® extended release formulation -XR |
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| Placebo | Placebo Comparator | placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keppra® extended release formulation - XR | Drug | 500mg extended release oral tablet, 2 tablets once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population | Number of POS over the treatment period standardized to 1 week period. | Treatment period (12 weeks) |
| Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population | Number of POS over the treatment period standardized to 1 week period | Treatment Period (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| POS Seizure Frequency Per Week Over Baseline and Treatment Period | Baseline Period (8 weeks) - Treatment Period (12 weeks) | |
| All (Type I+II+III) Seizures Frequency Per Week | Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures) |
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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 |
|---|---|---|---|---|---|---|
| N01235 1007 | Curitiba | Brazil | ||||
| N01235 2001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19317886 | Result | Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x. | |
| 19699156 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Baseline and Participant Flow data consists of the Intent-to-Treat (ITT) analysis group. The ITT group consists of all randomized subjects.
The N01235 study began recruitment in August 2006 with study completion occurring in May 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Keppra® | Keppra® extended release formulation (XR) |
| FG001 | Placebo | placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | oral tablets, 2 tablets once daily |
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| Treatment period (12 weeks) |
| 50% Response in Weekly POS Frequency | A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period. | Treatment period (12 weeks) |
| Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks | The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration. | over the treatment period (12 weeks) |
| Kuopio |
| Finland |
| N01235 2003 | Tampere | Finland |
| N01235 2002 | Turku | Finland |
| N01235 3008 | Chennai | India |
| N01235 3010 | Chennai | India |
| N01235 3012 | Gandhinagar | India |
| N01235 3003 | Hyderabad | India |
| N01235 3004 | Hyderabad | India |
| N01235 3001 | Lucknow | India |
| N01235 3009 | Madurai | India |
| N01235 3002 | Mumbai | India |
| N01235 3007 | Mumbai | India |
| N01235 3011 | Visakhapatnam | India |
| N01235 4006 | Aguascalientes | Mexico |
| N01235 4003 | Distrio Federal | Mexico |
| N01235 4001 | Guadalajara | Mexico |
| N01235 4005 | Puebla City | Mexico |
| N01235 5001 | Moscow | Russia |
| N01235 5002 | Moscow | Russia |
| N01235 5003 | Moscow | Russia |
| N01235 5005 | Moscow | Russia |
| N01235 5006 | Moscow | Russia |
| N01235 5007 | Moscow | Russia |
| N01235 5004 | Saint Petersburg | Russia |
| N01235 5009 | Saint Petersburg | Russia |
| N01235 5008 | Smolensk | Russia |
| N01235 6002 | Cape Town | South Africa |
| N01235 6003 | Umhlanga | South Africa |
| N01235 7001 | Kharkiv | Ukraine |
| N01235 7004 | Kharkiv | Ukraine |
| N01235 7005 | Lviv | Ukraine |
| N01235 7002 | Odesa | Ukraine |
| N01235 7003 | Poltava | Ukraine |
| Result |
| Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Keppra® | Keppra® extended release formulation (XR) |
| BG001 | Placebo | placebo |
| 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, 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population | Number of POS over the treatment period standardized to 1 week period. | Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.) | Posted | Least Squares Mean | Standard Error | seizures per week (log-transformed data) | Treatment period (12 weeks) |
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| Secondary | POS Seizure Frequency Per Week Over Baseline and Treatment Period | ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for levetiracetam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures | Posted | Median | Inter-Quartile Range | seizures per week | Baseline Period (8 weeks) - Treatment Period (12 weeks) |
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| Secondary | All (Type I+II+III) Seizures Frequency Per Week | Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures) | ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.) | Posted | Least Squares Mean | Standard Error | seizures per week (log-transformed data) | Treatment period (12 weeks) |
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| Secondary | 50% Response in Weekly POS Frequency | A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period. | ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period) | Posted | Number | Participants | Treatment period (12 weeks) |
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| Secondary | Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks | The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration. | ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period). | Posted | Number | Participants | over the treatment period (12 weeks) |
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| Primary | Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population | Number of POS over the treatment period standardized to 1 week period | Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period) | Posted | Least Squares Mean | Standard Error | seizures per week (log-transformed data) | Treatment Period (12 weeks) |
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Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
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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® | Keppra® extended release formulation (XR) | 6 | 77 | 23 | 77 | ||
| EG001 | Placebo | placebo | 2 | 79 | 21 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Simple partial seizures | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Stupor | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that 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 | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Male |
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| Finland |
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| Ukraine |
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| South Africa |
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| Russian Federation |
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| India |
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| Brazil |
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| Transf. of ANCOVA results on log data |
Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100*(1-exp(LSmeans Keppra -LSMeans Placebo)) |
| Percent reduction over Placebo |
| 14.4 |
| 95 |
| 0.9 |
| 26.0 |
| Superiority or Other (legacy) |
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