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The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label USL255 | Experimental | Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USL255 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | Open label treatment of up to 62 weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27084978 | Derived | Chung SS, Hogan RE, Blatt I, Lawson P B, Nguyen H, Clark AM, Anders B, Halvorsen MB; PREVAIL OLE Study Group. Long-term safety and sustained efficacy of USL255 (topiramate extended-release capsules) in patients with refractory partial-onset seizures. Epilepsy Behav. 2016 Jun;59:13-20. doi: 10.1016/j.yebeh.2016.03.005. Epub 2016 Apr 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label USL255 | Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day USL255 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ventura |
| California |
| United States |
| Gainsville | Florida | United States |
| Gulf Breeze | Florida | United States |
| Jacksonville | Florida | United States |
| Port Charlotte | Florida | United States |
| Lexington | Kentucky | United States |
| Waldorf | Maryland | United States |
| Chesterfield | Missouri | United States |
| St Louis | Missouri | United States |
| Somerset | New Jersey | 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 |
| Toronto | Canada |
| Santiago | Chile |
| Valdivia | Chile |
| Bonn | Germany |
| Munich | Germany |
| Athens | Greece |
| Thessaloniki | Greece |
| Bangalore | India |
| Dehradun | India |
| Hyderabad | India |
| Mangalore | India |
| Mumbai | India |
| New Delhi | India |
| Ashkelon | Israel |
| Holon | Israel |
| Nahariya | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Auckland | New Zealand |
| Gdansk | Poland |
| Katowice | 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 |
| Valencia | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label USL255 | Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day USL255 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations | The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study. | Posted | Number | participants | Open label treatment of up to 62 weeks |
|
|
|
Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
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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 | Open-label USL255 | Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day USL255 | 14 | 210 | 61 | 210 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhea infectious | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Balance disorder | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | 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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| Title | Measurements |
|---|---|
|
| No. with severe AEs |
|
| No. with serious AEs |
|
| No. with TEAEs leading to study discontinuation |
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| No. of deaths related to study drug |
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| No. of deaths unrelated to study drug |
|