A Phase 3 interventional study of Oxcarbazepine XR in Partial Epilepsy, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 58 sites in 8 countries. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2017-05-31.
Sponsored by Supernus Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
NAP
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 214 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Open Label Study
Drug: Oxcarbazepine XR
Open Label Study
Also known as: SPN-804O
Percent Change in Seizure Rate
Measured as change from baseline to end of study
Time frame: one year
| Milestone | Oxcarbazepine XR |
|---|---|
| Started | 214 |
| Completed | 179 |
| Not completed | 35 |
| Withdrew: Adverse event | 10 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Physician decision | 5 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Various | 6 |
Measured as change from baseline to end of study
| percentage of change in seizure rate | Oxcarbazepine XR |
|---|---|
| Percent Change in Seizure Rate | -26.3 (-100.0 to 344.7) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxcarbazepine XR | — | 18/214 (8.4%) | 124/214 (57.9%) |
| Event | Oxcarbazepine XR |
|---|---|
| Grand Mal ConvulsionNervous system disorders | 2/214 |
| Non-Cardiac Chest PainGeneral disorders | 2/214 |
| EpilepsyNervous system disorders | 2/214 |
| HypothermiaGeneral disorders | 1/214 |
| Spinal FractureInjury, poisoning and procedural complications | 1/214 |
| AtaxiaNervous system disorders | 1/214 |
| Transient Ischaemic AttackNervous system disorders | 1/214 |
| DizzinessNervous system disorders | 1/214 |
| ConvulsionNervous system disorders | 1/214 |
| Prostatic Specific Antigen IncreasedInvestigations | 1/214 |
| Event | Oxcarbazepine XR |
|---|---|
| DizzinessNervous system disorders | 33/214 |
| HeadacheNervous system disorders | 24/214 |
| DiplopiaEye disorders | 20/214 |
| NauseaGastrointestinal disorders | 16/214 |
| VomitingGastrointestinal disorders | 13/214 |
| SomnolenceNervous system disorders | 12/214 |
| Balance DisorderNervous system disorders | 10/214 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 10/214 |
| Age, Continuous(Years) | Oxcarbazepine XR |
|---|---|
| Mean | 37.4 (18 to 67) |
| Sex: Female, Male(Participants) | Oxcarbazepine XR |
|---|---|
| Female | 111 |
| Male | 103 |
| Region of Enrollment(participants) | Oxcarbazepine XR |
|---|---|
| United States | 43 |
| Mexico | 30 |
| Canada | 2 |
| Poland | 31 |
| Romania | 12 |
| Croatia | 6 |
| Russian Federation | 64 |
| Bulgaria | 26 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Supernus Pharmaceuticals, Inc.