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

Primary Purpose

Partial Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oxcarbazepine XR
Sponsored by
Supernus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsy

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Oxcarbazepine XR

Arm Description

Open Label Study

Outcomes

Primary Outcome Measures

Percent Change in Seizure Rate
Measured as change from baseline to end of study

Secondary Outcome Measures

Full Information

First Posted
May 22, 2009
Last Updated
May 1, 2017
Sponsor
Supernus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00908349
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxcarbazepine XR
Arm Type
Other
Arm Description
Open Label Study
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine XR
Other Intervention Name(s)
SPN-804O
Intervention Description
Open Label Study
Primary Outcome Measure Information:
Title
Percent Change in Seizure Rate
Description
Measured as change from baseline to end of study
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet K Johnson, PhD
Organizational Affiliation
Supernus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Northport
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Riverside
State/Province
California
Country
United States
City
West Los Angeles
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Missoula
State/Province
Montana
Country
United States
City
New York
State/Province
New York
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Baytown
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Blagoevgrad
Country
Bulgaria
City
Pleven
Country
Bulgaria
City
Ruse
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Calgary
State/Province
Alberta
Country
Canada
City
Greenfield Park
State/Province
Quebec
Country
Canada
City
Dubrovnik
Country
Croatia
City
Zagreb
Country
Croatia
City
Col. Las Palmas
State/Province
Chihuahua
Country
Mexico
City
Mexico City
State/Province
DF
Country
Mexico
City
Col. Guillermina
State/Province
Durango
Country
Mexico
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Zapopan
State/Province
Jalisco
Country
Mexico
City
San Luis Potosi
State/Province
San Luis Potosí
Country
Mexico
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

12. IPD Sharing Statement

Plan to Share IPD
No

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

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