Clinical trial NCT00772603: Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Official title: Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies, Partial
Keywords: Partial onset epilepsy
Partial onset seizures
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2008-10-15
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PCH(T), ITT
timeFrame: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
Secondary outcomes:
measure: PCH(M)- ITT
timeFrame: Change at 12 weeks (Maintenance Period) compared to Baseline
measure: Responder Rate, ITT
timeFrame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
measure: Seizure-Free Rates, ITT
timeFrame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
measure: Seizure Free Rate, ITT, (M)
timeFrame: At the end of 12 weeks (Maintenance Period)
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Riverside
country: United States
state: California
city: West Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Missoula
country: United States
state: Montana
city: Camden
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Baytown
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Blagoevgrad
country: Bulgaria
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Edmonton
country: Canada
state: Alberta
city: Greenfield Park
country: Canada
state: Quebec
city: Dubrovnik
country: Croatia
city: Rijeka
country: Croatia
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
city: Ciudad Juárez
country: Mexico
state: Chihuahua
city: Mexico City
country: Mexico
state: DF
city: Toluca
country: Mexico
state: Estado de Mexico
city: Guadalajara
country: Mexico
state: Jalisco
city: Zapopan
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
state: San Luis Potosí
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Durango
country: Mexico
city: Puebla
country: Mexico
city: Gizycko
country: Poland
city: Katowice
country: Poland
city: Konskie
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Wilkowice
country: Poland
city: Zabrze
country: Poland
city: Bucharest
country: Romania
city: Campulung Muscel
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: St Petersburg
country: Russian Federation
state: Sestroretsk
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Janet K Johnson, PhD
role: STUDY_DIRECTOR
References: