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

• Sponsor: Supernus Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Supernus Pharmaceuticals, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Partial Epilepsy	Drug: Oxcarbazepine XR	Phase 3

Detailed Description:

NAP

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	214 participants
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
Study Start Date :	June 2009
Actual Primary Completion Date :	November 2011
Actual Study Completion Date :	November 2011

Arms and Interventions

Arm	Intervention/treatment
Oxcarbazepine XR; Open Label Study	Drug: Oxcarbazepine XR; Open Label Study; Other Name: SPN-804O

Outcome Measures

Primary Outcome Measures :

1. Percent Change in Seizure Rate [ Time Frame: one year ]
   Measured as change from baseline to end of study

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 66 Years (Adult, Older Adult)
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

  Show 58 Study Locations

Sponsors and Collaborators

Supernus Pharmaceuticals, Inc.

Investigators

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Study Director:	Janet K Johnson, PhD	Supernus Pharmaceuticals, Inc.

More Information

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Responsible Party:	Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00908349 History of Changes
Other Study ID Numbers:	804P302
First Posted:	May 25, 2009
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:

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Epilepsy; Epilepsies, Partial; 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