Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy - Full Text View

Sponsor:	Supernus Pharmaceuticals, Inc.
Information provided by:	Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00908349

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	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy on up to Three Concomitant Antiepileptic Medications

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

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

Primary Outcome Measures:

Evaluate the safety and tolerability of long-term administration of oxcarbazepine extended-release in the treatment of seizures of partial origin in subjects with refractory epilepsy on up to three concomitant antiepileptic drugs (AEDs) in adults. [ Time Frame: 2010-2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the effect on seizure frequency of long-term administration of adjunctive OXC XR in the treatment of seizures of partial origin in subjects with refractory epilepsy on other AEDs; and to monitor the pattern of dose adjustment over time. [ Time Frame: 2010-2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxcarbazepine Open Label Study	Drug: Oxcarbazepine Open Label Study Other Name: NAP

Detailed Description:

NAP

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908349

Show 83 Study Locations

Sponsors and Collaborators

Supernus Pharmaceuticals, Inc.

Investigators

Study Director:

Paolo Baroldi, MD, PhD

Supernus Pharmaceuticals

More Information

No publications provided

Responsible Party:	Dawn Louro, Supernus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00908349 History of Changes
Other Study ID Numbers:	804P302
Study First Received:	May 22, 2009
Last Updated:	August 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012