Epilepsies, PartialPhase 3PROSPER1NCT00772603
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
A Phase 3 study testing 2400mg SPN-804 and 1200mg SPN-804 in people with Epilepsies, Partial, run by Supernus Pharmaceuticals, Inc. at 71 sites in 8 countries.
Trial summary
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- 2400mg SPN-804 and 1200mg SPN-804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 71 sitesin 8 countries
- Study dates
- Nov 2008to Nov 2010
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Refractory to at least one AED
- No progressive neurological conditions by recent MRI/CT
- Adequate birth control in women of child-bearing potential
Who cannot join
- 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
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- 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
Trial locations and contacts
71 sites in 8 countries.
71 sites in 8 countries
United States23 sites
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Baytown, Texas
Study site
Bethesda, Maryland
Study site
Camden, New Jersey
Study site
Huntsville, Alabama
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Miami, Florida
Study site
Missoula, Montana
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Northport, Alabama
Study site
Oklahoma City, Oklahoma
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Riverside, California
Study site
Sarasota, Florida
Study site
Springfield, Illinois
Study site
Temple, Texas
Study site
Tucson, Arizona
Study site
West Los Angeles, California
Russia12 sites
Study site
Kazan'
Study site
Kirov
Study site
Kursk
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Novosibirsk
Study site
Pyatigorsk
Study site
Saint Petersburg, Sestroretsk
Study site
Saint Petersburg
Study site
Samara
Study site
Smolensk
Study site
Yaroslavl
Mexico11 sites
Study site
Aguascalientes, Aguascalientes
Study site
Chihuahua City, Chihuahua
Study site
Ciudad Juárez, Chihuahua
Study site
Durango, Durango
Study site
Guadalajara, Jalisco
Study site
Mexico City, Mexico City
Study site
Monterrey, Nuevo León
Study site
Puebla City, Puebla
Study site
San Luis Potosí City, San Luis Potosí
Study site
Toluca, State of Mexico
Study site
Zapopan, Jalisco
Poland9 sites
Study site
Giżycko
Study site
Gmina Końskie
Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Warsaw
Study site
Wilkowice
Study site
Zabrze
Bulgaria6 sites
Study site
Blagoevgrad
Study site
Pleven
Study site
Plovdiv
Study site
Rousse
Study site
Sofia
Study site
Varna
Croatia4 sites
Study site
Dubrovnik
Study site
Rijeka
Study site
Zadar
Study site
Zagreb
Romania4 sites
Study site
Bucharest
Study site
Campulung Muscel
Study site
Cluj-Napoca
Study site
Craiova
About this study
Official title: Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Read the detailed description
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.
- Conditions
- Epilepsies, Partial
- Being tested
- Placebo, 2400mg SPN-804, 1200mg SPN-804
- Keywords
- Partial onset epilepsy, Partial onset seizures
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called sham treatment
Non-active tablet identical to study drug tablets
2400mg SPN-804Drug
Also called Oxcarbazepine extended-release, Oxtellar XR, Oxtellar
tablets containing 600mg OXC XR, identical to non-active tablets
1200mg SPN-804Drug
Also called Oxcarbazepine extended-release, Oxtellar XR, Oxtellar
two active tablets and two non-active tablets, all identical
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo - four identical tablets taken orally once daily Receives: Drug: Placebo |
| 2400 mg SPN-804 | Active comparator | 2400mg OXC XR taken orally once daily as four identical tablets Receives: Drug: 2400mg SPN-804 |
| 1200mg SPN-804 | Active comparator | 1200mg OXC XR taken orally once daily as four identical tablets Receives: Drug: 1200mg SPN-804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCH(T), ITT
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.
Measured: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
Secondary outcomes (4)
PCH(M)- ITT
Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population
Measured: Change at 12 weeks (Maintenance Period) compared to Baseline
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
Measured: 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
Measured: 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
Measured: At the end of 12 weeks (Maintenance Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Janet K Johnson, PhD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772603
- Sponsor's protocol ID
- 804P301
- Acronym
- PROSPER1
- Status last verified
- Dec 2013
- First submitted
- 10 Oct 2008
- Last updated
- 11 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No