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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908349
First Posted: May 25, 2009
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
  Purpose
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Condition Intervention Phase
Partial Epilepsy Drug: Oxcarbazepine XR Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Percent Change in Seizure Rate [ Time Frame: one year ]
    Measured as change from baseline to end of study


Enrollment: 214
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oxcarbazepine XR
Open Label Study
Drug: Oxcarbazepine XR
Open Label Study
Other Name: SPN-804O

Detailed Description:
NAP
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908349


  Show 58 Study Locations
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
Study Director: Janet K Johnson, PhD Supernus Pharmaceuticals, Inc.
  More Information

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00908349     History of Changes
Other Study ID Numbers: 804P302
First Submitted: May 22, 2009
First Posted: May 25, 2009
Results First Submitted: February 25, 2016
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers