Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
PROSPER1
Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
1 other identifier
interventional
366
8 countries
71
Brief Summary
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2008
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
February 11, 2014
CompletedFebruary 11, 2014
December 1, 2013
1.4 years
October 10, 2008
April 9, 2013
December 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
PCH(M)- ITT
Change at 12 weeks (Maintenance Period) compared to Baseline
Responder Rate, ITT
At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure-Free Rates, ITT
At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure Free Rate, ITT, (M)
At the end of 12 weeks (Maintenance Period)
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo - four identical tablets taken orally once daily
2400 mg SPN-804
ACTIVE COMPARATOR2400mg OXC XR taken orally once daily as four identical tablets
1200mg SPN-804
ACTIVE COMPARATOR1200mg OXC XR taken orally once daily as four identical tablets
Interventions
tablets containing 600mg OXC XR, identical to non-active tablets
two active tablets and two non-active tablets, all identical
Eligibility Criteria
You may qualify if:
- Capable of complying with the study procedures.
- Able to provide written informed consent
- Male or female aged 18 to 65 years, inclusive.
- Diagnosis of partial onset seizures
- Minimum of three seizures per 28 days
- Receiving treatment with 1-3 AEDs
- Refractory to at least one AED
- No progressive neurological conditions by recent MRI/CT
- Adequate birth control in women of child-bearing potential
You may not qualify if:
- Refractory to OXC for reasons of efficacy
- Recent status epilepticus
- Recent non-epileptic seizures
- Current diagnosis of major depression
- Recent suicidal plan or intent or more than one attempt
- Current use of oxcarbazepine, felbamate for \< 18 months, phenytoin with levels \>15mcg/mL or frequent need for rescue benzodiazepines
- Current use of sodium-lowering non-seizure medications.
- Clinically significant hepatic, renal, or cardiovascular function
- History of recent substance abuse
- Females who are pregnant or lactating.
- Hypersensitivity to OXC or related drugs
- Difficulty swallowing study medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Supernus Pharmaceuticals, Inc.lead
- Parexelcollaborator
Study Sites (71)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Northport, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Riverside, California, United States
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West Los Angeles, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Sarasota, Florida, United States
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Atlanta, Georgia, United States
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Springfield, Illinois, United States
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Lexington, Kentucky, United States
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Bethesda, Maryland, United States
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Missoula, Montana, United States
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Camden, New Jersey, United States
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New York, New York, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Baytown, Texas, United States
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Temple, Texas, United States
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Blagoevgrad, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Edmonton, Alberta, Canada
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Greenfield Park, Quebec, Canada
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Dubrovnik, Croatia
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Rijeka, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Aguascalientes, Aguascalientes, Mexico
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Chihuahua City, Chihuahua, Mexico
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Ciudad Juárez, Chihuahua, Mexico
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Puebla City, Puebla, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Toluca, State of Mexico, Mexico
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Giżycko, Poland
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Gmina Końskie, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
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Wilkowice, Poland
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Zabrze, Poland
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Bucharest, Romania
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Campulung Muscel, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Saint Petersburg, Sestroretsk, Russia
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Kazan', Russia
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Kirov, Russia
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Kursk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Pyatigorsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Smolensk, Russia
Unknown Facility
Yaroslavl, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stefan Schwabe, M.D., Ph.D., Chief Medical Officer
- Organization
- Supernus Pharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
Janet K Johnson, PhD
Supernus Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 15, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2010
Study Completion
November 1, 2010
Last Updated
February 11, 2014
Results First Posted
February 11, 2014
Record last verified: 2013-12