Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

NCT00908349 | Completed Phase 3 Results

• 1 other identifier: 804P302
• Study Type: interventional
• Target: 214
• Locations: 8 countries
• Sites: 58

Brief Summary

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

Conditions

Partial Epilepsy

Outcome Measures

Primary Outcomes (1)

• Percent Change in Seizure Rate

  Measured as change from baseline to end of study

  one year

Study Arms (1)

Oxcarbazepine XR

OTHER

Open Label Study

Drug: Oxcarbazepine XR

Interventions

Oxcarbazepine XR DRUG

Open Label Study

Also known as: SPN-804O

Oxcarbazepine XR

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent and agree to comply with study procedures.
• Male or female aged 18 to 66 years, inclusive.
• Successful completion of the 804P301 study.
• 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.

You may not qualify if:

• 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.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (58)

Unknown Facility

Huntsville, Alabama, United States

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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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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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New York, New York, United States

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Oklahoma City, Oklahoma, 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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Rousse, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Calgary, Alberta, Canada

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Greenfield Park, Quebec, Canada

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Dubrovnik, Croatia

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Zagreb, Croatia

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Col. Las Palmas, Chihuahua, Mexico

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Col. Guillermina, 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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San Luis Potosí City, San Luis Potosí, Mexico

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Aguascalientes, Mexico

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Puebla City, Mexico

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Giżycko, 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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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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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

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MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Janet K. Johnson, PhD
• Organization: Supernus Pharmaceuticals, Inc

jjohnson@supernus.com

301-838-2623

Study Officials

• Janet K Johnson, PhD

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (8); RU (10); CR (2); BU (5); CA (2); RO (4); PL (7); US (20)