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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo - four identical tablets taken orally once daily |
|
| 2400 mg SPN-804 | Active Comparator | 2400mg OXC XR taken orally once daily as four identical tablets |
|
| 1200mg SPN-804 | Active Comparator | 1200mg OXC XR taken orally once daily as four identical tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Non-active tablet identical to study drug tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCH(T), ITT | Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population. | Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PCH(M)- ITT | Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population | Change at 12 weeks (Maintenance Period) compared to Baseline |
| Responder Rate, ITT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet K Johnson, PhD | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
Patients had at least three partial seizures per 28 days during an 8 week Baseline Period. Subjects were receiving treatment with one to three antiepileptic drugs and were on stable treatment for a minimum of 4 weeks. Subjects with a diagnosis other than partial epilepsy were excluded.
Adult patients with refractory partial onset epilepsy were recruited from December 2009 to March 2011 at clinical sites in 8 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2400mg/Day SPN-804 | 2400mg of SPN-804O once daily |
| FG001 | 1200mg/Day SPN-804 | 1200mg SPN-804O once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 2400mg SPN-804 | Drug | tablets containing 600mg OXC XR, identical to non-active tablets |
|
|
| 1200mg SPN-804 | Drug | two active tablets and two non-active tablets, all identical |
|
|
Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population
| At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) |
| Seizure-Free Rates, ITT | Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population | At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) |
| Seizure Free Rate, ITT, (M) | Percent of patients seizure-free during Maintenance, Intent-to-Treat population | At the end of 12 weeks (Maintenance Period) |
| Northport |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Riverside | California | United States |
| West Los Angeles | California | United States |
| Aurora | Colorado | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Sarasota | Florida | United States |
| Atlanta | Georgia | United States |
| Springfield | Illinois | United States |
| Lexington | Kentucky | United States |
| Bethesda | Maryland | United States |
| Missoula | Montana | United States |
| Camden | New Jersey | United States |
| New York | New York | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Baytown | Texas | United States |
| Temple | Texas | United States |
| Blagoevgrad | Bulgaria |
| Pleven | Bulgaria |
| Plovdiv | Bulgaria |
| Rousse | Bulgaria |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Edmonton | Alberta | Canada |
| Greenfield Park | Quebec | Canada |
| Dubrovnik | Croatia |
| Rijeka | Croatia |
| Zadar | Croatia |
| Zagreb | Croatia |
| Aguascalientes | Aguascalientes | Mexico |
| Chihuahua City | Chihuahua | Mexico |
| Ciudad Juárez | Chihuahua | Mexico |
| Durango | Durango | Mexico |
| Guadalajara | Jalisco | Mexico |
| Zapopan | Jalisco | Mexico |
| Mexico City | Mexico City | Mexico |
| Monterrey | Nuevo León | Mexico |
| Puebla City | Puebla | Mexico |
| San Luis Potosà City | San Luis Potosà | Mexico |
| Toluca | State of Mexico | Mexico |
| Giżycko | Poland |
| Gmina Końskie | Poland |
| Katowice | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Warsaw | Poland |
| Wilkowice | Poland |
| Zabrze | Poland |
| Bucharest | Romania |
| Campulung Muscel | Romania |
| Cluj-Napoca | Romania |
| Craiova | Romania |
| Saint Petersburg | Sestroretsk | Russia |
| Kazan' | Russia |
| Kirov | Russia |
| Kursk | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Novosibirsk | Russia |
| Pyatigorsk | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Smolensk | Russia |
| Yaroslavl | Russia |
| FG002 |
| Placebo |
Placebo once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2400mg/Day SPN-804 | 2400mg SPN-804O once daily |
| BG001 | 1200mg/Day SPN-804 | 1200mg SPN-804O given once daily |
| BG002 | Placebo | Placebo given once daily. |
| BG003 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | PCH(T), ITT | Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population. | All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug. | Posted | Median | Full Range | percentage of change | Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline |
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| Secondary | PCH(M)- ITT | Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population | All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period. | Posted | Median | 95% Confidence Interval | percentage of change | Change at 12 weeks (Maintenance Period) compared to Baseline |
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| Secondary | Responder Rate, ITT | Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population | All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug. | Posted | Number | percentage of patients | At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) |
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| Secondary | Seizure-Free Rates, ITT | Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population | All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug. | Posted | Number | percentage of patients | At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) |
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| Secondary | Seizure Free Rate, ITT, (M) | Percent of patients seizure-free during Maintenance, Intent-to-Treat population | All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period. | Posted | Number | percentage of patients | At the end of 12 weeks (Maintenance Period) |
|
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All randomized subjects who took at least one dose of study drug.
Safety was assessed using adverse events (AEs), clinical laboratory results, vital signs, physical and neurological examinations, and electrocardiograms (ECGs).
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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 | 2400mg/Day SPN-804 | 2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets | 10 | 123 | 69 | 123 | ||
| EG001 | 1200mg/Day SPN-804 | 1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets. | 7 | 122 | 57 | 122 | ||
| EG002 | Placebo | placebo QD, given as four placebo tablets | 7 | 121 | 55 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Skull fractured, base | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatreamia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Pituitary tumor, benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Convulsions/complex partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
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| Post-ictal state | Nervous system disorders | MedDRA | Systematic Assessment |
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| Nystagmus | Nervous system disorders | MedDRA | Systematic Assessment |
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| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Stevens-Johnson Syndrome | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Balance Disorder | Nervous system disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefan Schwabe, M.D., Ph.D., Chief Medical Officer | Supernus Pharmaceuticals, Inc | 301-838-2500 | 2527 | sschwabe@supernus.com |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Mexico |
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| Canada |
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| Poland |
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| Romania |
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| Croatia |
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| Russian Federation |
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| Bulgaria |
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| A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050. | Wilcoxon (Mann-Whitney) | =0.078 | P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons. | Median Difference (Net) | -10.30 | 2-Sided | 95 | -22.30 | 1.20 | No | Superiority or Other |
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