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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016996-31 | EudraCT Number |
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The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USL255 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USL255 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. | 11 weeks | |
| Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25461205 | Derived | Hogan RE, Blatt I, Lawson B, Nagaraddi V, Fakhoury TA, Anders B, Clark AM, Laine D, Halvorsen MB, Chung SS. Efficacy of once-daily extended-release topiramate (USL255): a subgroup analysis based on the level of treatment resistance. Epilepsy Behav. 2014 Dec;41:136-9. doi: 10.1016/j.yebeh.2014.09.061. Epub 2014 Oct 21. | |
| 24902983 |
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Subject had to have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days during the 8-week baseline to be randomized into the trial.
This study was conducted in 16 countries (Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russia, South Africa, Spain, and United States). At least 1 subject was enrolled at 66 study centers, of which 60 study centers randomly assigned at least 1 subject to study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | USL255 | Titration of 50 mg in weekly increments over 3 weeks to 200 mg |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 3 weeks (weeks 1-3) |
| Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. | 3 weeks (weeks 1-3) |
| Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase. | 11 weeks |
| Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline. | 3 weeks (weeks 1-3) |
| Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. | 11 weeks |
| Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. | 8 weeks (weeks 4-11) |
| Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. | 8 weeks (weeks 4-11) |
| Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. | 8 weeks (weeks 4-11) |
| Ventura |
| California |
| United States |
| Gainesville | Florida | United States |
| Gulf Breeze | Florida | United States |
| Jacksonville | Florida | United States |
| Pensacola | Florida | United States |
| Port Charlotte | Florida | United States |
| Boise | Idaho | United States |
| Lexington | Kentucky | United States |
| Waldorf | Maryland | United States |
| Chesterfield | Missouri | United States |
| St Louis | Missouri | United States |
| New Brunswick | New Jersey | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Toledo | Ohio | United States |
| Dallas | Texas | United States |
| Temple | Texas | United States |
| Milwaukee | Wisconsin | United States |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| Salta | Argentina |
| Villa Nueva | Argentina |
| Bedford Park | Australia |
| Clayton | Australia |
| Fitzory | Australia |
| Heidelberg West | Australia |
| Parkville | Australia |
| Randwick | Australia |
| Woodville | Australia |
| Bruges | Belgium |
| Duffel | Belgium |
| Leuven | Belgium |
| Greenfield Park | Canada |
| Santiago | Chile |
| Valdivia | Chile |
| Bonn | Germany |
| München | Germany |
| Athens | Greece |
| Thessaloniki | Greece |
| Budapest | Hungary |
| Bangalore | India |
| Dehradun | India |
| Hyderabad | India |
| Mangalore | India |
| New Delhi | India |
| Ashkelon | Israel |
| Haifa | Israel |
| Holon | Israel |
| Nahariya | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Auckland | New Zealand |
| Gdansk | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Warsaw | Poland |
| Kazan' | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Tyumen | Russia |
| Yaroslavi | Russia |
| Cape Town | South Africa |
| Badalona | Spain |
| Barakaldo | Spain |
| Granada | Spain |
| Madrid | Spain |
| Chung SS, Fakhoury TA, Hogan RE, Nagaraddi VN, Blatt I, Lawson B, Arnold S, Anders B, Clark AM, Laine D, Meadows RS, Halvorsen MB; PREVAIL Study Group. Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. Epilepsia. 2014 Jul;55(7):1077-87. doi: 10.1111/epi.12660. Epub 2014 Jun 5. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | USL255 | Titration of 50 mg in weekly increments over 3 weeks to 200 mg |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug | Posted | Median | Full Range | Percent Reduction | 11 weeks |
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| Secondary | Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug | Posted | Number | Percentage of participants | 11 weeks |
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| Secondary | Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. | Posted | Number | Percentage of participants | 3 weeks (weeks 1-3) |
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| Secondary | Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug | Posted | Median | Full Range | Percent Reduction | 3 weeks (weeks 1-3) |
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| Secondary | Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug | Posted | Median | Full Range | Percent Reduction | 11 weeks |
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| Secondary | Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug | Posted | Number | Percentage of participants | 3 weeks (weeks 1-3) |
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| Secondary | Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug | Posted | Number | Percentage of participants | 11 weeks |
|
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| Secondary | Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase. | Posted | Number | Percentage of participants | 8 weeks (weeks 4-11) |
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| Secondary | Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase. | Posted | Median | Full Range | Percent Reduction | 8 weeks (weeks 4-11) |
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| Secondary | Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. | Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase. | Posted | Number | Percentage of participants | 8 weeks (weeks 4-11) |
|
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Adverse events with onset after the start of study medication and up to 30 days after the last dose of study drug are reported.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once for that SOC.
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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 | USL255 | Titration of 50 mg in weekly increments over 3 weeks to 200 mg | 2 | 124 | 35 | 124 | ||
| EG001 | Placebo | Placebo | 2 | 125 | 14 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lobar Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Physical Assault | Social circumstances | MedDRA 11.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Epileptic Psychosis | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bob Anders, Sr. Director of Clinical Operations | Upsher-Smith Laboratories, Inc. | 763-315-2000 | Bob.Anders@upsher-smith.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
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| Male |
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| Median Difference (Net) |
| 18.5 |
| 2-Sided |
| 95 |
| 8.53 |
| 28.1 |
| No |
| Superiority or Other |
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