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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Epilepsy
Intervention Drug: Oxcarbazepine XR
Enrollment 214
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxcarbazepine XR
Hide Arm/Group Description Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
Period Title: Overall Study
Started 214
Completed 179
Not Completed 35
Reason Not Completed
Adverse Event             10
Withdrawal by Subject             9
Physician Decision             5
Lost to Follow-up             5
Various             6
Arm/Group Title Oxcarbazepine XR
Hide Arm/Group Description

Open Label Study

Oxcarbazepine XR: Open Label Study

Overall Number of Baseline Participants 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 214 participants
37.4
(18 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants
Female
111
  51.9%
Male
103
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants
United States 43
Mexico 30
Canada 2
Poland 31
Romania 12
Croatia 6
Russian Federation 64
Bulgaria 26
1.Primary Outcome
Title Percent Change in Seizure Rate
Hide Description Measured as change from baseline to end of study
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxcarbazepine XR
Hide Arm/Group Description:
Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
Overall Number of Participants Analyzed 214
Median (Full Range)
Unit of Measure: percentage of change in seizure rate
-26.3
(-100.0 to 344.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxcarbazepine XR
Hide Arm/Group Description Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
All-Cause Mortality
Oxcarbazepine XR
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxcarbazepine XR
Affected / at Risk (%) # Events
Total   18/214 (8.41%)    
General disorders   
Hypothermia  1  1/214 (0.47%)  1
Non-Cardiac Chest Pain  2  2/214 (0.93%)  2
Infections and infestations   
Pyelonephritis Acute  2  1/214 (0.47%)  1
Injury, poisoning and procedural complications   
Spinal Fracture  1  1/214 (0.47%)  1
Investigations   
Prostatic Specific Antigen Increased  2  1/214 (0.47%)  1
Nervous system disorders   
Ataxia  2  1/214 (0.47%)  1
Transient Ischaemic Attack  2  1/214 (0.47%)  1
Dizziness  2  1/214 (0.47%)  1
Convulsion  2  1/214 (0.47%)  1
Grand Mal Convulsion  2  2/214 (0.93%)  2
Epilepsy  2  2/214 (0.93%)  2
Encephalopathy  2  1/214 (0.47%)  1
Psychiatric disorders   
Suicidal Behaviour  2  1/214 (0.47%)  1
Renal and urinary disorders   
Nephrolithiasis  2  1/214 (0.47%)  1
Vascular disorders   
Thrombosis  2  1/214 (0.47%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxcarbazepine XR
Affected / at Risk (%) # Events
Total   124/214 (57.94%)    
Eye disorders   
Diplopia  20/214 (9.35%) 
Gastrointestinal disorders   
Nausea  16/214 (7.48%) 
Vomiting  13/214 (6.07%) 
Nervous system disorders   
Dizziness  33/214 (15.42%) 
Headache  24/214 (11.21%) 
Somnolence  12/214 (5.61%) 
Balance Disorder  10/214 (4.67%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract infection  10/214 (4.67%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janet K. Johnson, PhD
Organization: Supernus Pharmaceuticals, Inc
Phone: 301-838-2623
EMail: jjohnson@supernus.com
Layout table for additonal 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