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Trial record 99 of 146 for:    epilepsy AND Bethesda

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

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.
 
ClinicalTrials.gov Identifier: NCT00908349
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2009
First Posted Date  ICMJE May 25, 2009
Results First Submitted Date  ICMJE February 25, 2016
Results First Posted Date  ICMJE May 31, 2017
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE June 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2017)
Percent Change in Seizure Rate [ Time Frame: one year ]
Measured as change from baseline to end of study
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
Evaluate the safety and tolerability of long-term administration of adjunctive OXC XR in the treatment of seizures of partial origin in subjects with refractory epilepsy on up to two concomitant antiepileptic drugs (AEDs).
Change History Complete list of historical versions of study NCT00908349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
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;To monitor the pattern of dose adjustment over time.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Official Title  ICMJE 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
Brief Summary Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
Detailed Description NAP
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Partial Epilepsy
Intervention  ICMJE Drug: Oxcarbazepine XR
Open Label Study
Other Name: SPN-804O
Study Arms  ICMJE Oxcarbazepine XR
Open Label Study
Intervention: Drug: Oxcarbazepine XR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
214
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
360
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Croatia,   Mexico,   Poland,   Romania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908349
Other Study ID Numbers  ICMJE 804P302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Supernus Pharmaceuticals, Inc.
Study Sponsor  ICMJE Supernus Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janet K Johnson, PhD Supernus Pharmaceuticals, Inc.
PRS Account Supernus Pharmaceuticals, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP