Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00908349
First received: May 22, 2009
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  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 3

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:

MedlinePlus related topics: Epilepsy Seizures
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
Study Completion Date: June 2012
Primary Completion Date: November 2011 (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

  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
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: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00908349     History of Changes
Other Study ID Numbers: 804P302
Study First Received: May 22, 2009
Last Updated: June 18, 2012
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 May 16, 2013