Clinical trial NCT00908349: Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Official title: Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Epilepsy
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Detailed description: NAP

Eligibility criteria: Inclusion Criteria

1. Able to provide written informed consent and agree to comply with study procedures.
2. Male or female aged 18 to 66 years, inclusive.
3. Successful completion of the 804P301 study.
4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication \[SM\] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to SM administration\] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.

Exclusion Criteria

1. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Primary outcomes:
measure: Percent Change in Seizure Rate
timeFrame: one year
Secondary outcomes:
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: 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: New York
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
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: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Greenfield Park
country: Canada
state: Quebec
city: Dubrovnik
country: Croatia
city: Zagreb
country: Croatia
city: Col. Las Palmas
country: Mexico
state: Chihuahua
city: Mexico City
country: Mexico
state: DF
city: Col. Guillermina
country: Mexico
state: Durango
city: Guadalajara
country: Mexico
state: Jalisco
city: Zapopan
country: Mexico
state: Jalisco
city: San Luis Potosi
country: Mexico
state: San Luis Potosí
city: Aguascalientes
country: Mexico
city: Puebla
country: Mexico
city: Gizycko
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Wilkowice
country: Poland
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Câmpulung
country: Romania
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Janet K Johnson, PhD
role: STUDY_DIRECTOR
References: