Partial Epilepsy
Conditions
Brief summary
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
Detailed description
NAP
Interventions
DRUGOxcarbazepine XR
Open Label Study
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Seizure Rate | one year | Measured as change from baseline to end of study |
Countries
Bulgaria, Canada, Croatia, Mexico, Poland, Romania, Russia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxcarbazepine XR Open Label Study
Oxcarbazepine XR: Open Label Study | 214 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Various | 6 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Oxcarbazepine XR |
|---|---|
| Age, Continuous | 37.4 Years |
| Region of Enrollment Bulgaria | 26 participants |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment Croatia | 6 participants |
| Region of Enrollment Mexico | 30 participants |
| Region of Enrollment Poland | 31 participants |
| Region of Enrollment Romania | 12 participants |
| Region of Enrollment Russian Federation | 64 participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 124 / 214 |
| serious Total, serious adverse events | 18 / 214 |
Outcome results
Primary
Percent Change in Seizure Rate
Measured as change from baseline to end of study
Time frame: one year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxcarbazepine XR | Percent Change in Seizure Rate | -26.3 percentage of change in seizure rate |