Trial · NCT00908349
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
NCT00908349, Phase 3, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2017-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy. Trials, record NCT00908349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00908349
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
- NCT number
- NCT00908349
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Partial Epilepsy
- Interventions
- Oxcarbazepine XR
- First posted
- 2009-05-25
- Last updated
- 2017-05-31
- Results first posted
- 2017-05-31
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Seizure Rate | one year | Measured as change from baseline to end of study |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Seizure Rate | one year | percentage of change in seizure rate | MEDIAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Seizure Rate | Oxcarbazepine XR | -26.3 | Full Range -100.0 to 344.7 | percentage of change in seizure rate |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxcarbazepine XR | 214 | |
| Overall Study | COMPLETED | Oxcarbazepine XR | 179 | |
| Overall Study | NOT COMPLETED | Oxcarbazepine XR | 35 |
Source ClinicalTrials.gov
Adverse events23
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Oxcarbazepine XR | 33 | 214 | |
| other | Headache | Nervous system disorders | Oxcarbazepine XR | 24 | 214 | |
| other | Diplopia | Eye disorders | Oxcarbazepine XR | 20 | 214 | |
| other | Nausea | Gastrointestinal disorders | Oxcarbazepine XR | 16 | 214 | |
| other | Vomiting | Gastrointestinal disorders | Oxcarbazepine XR | 13 | 214 | |
| other | Somnolence | Nervous system disorders | Oxcarbazepine XR | 12 | 214 | |
| other | Balance Disorder | Nervous system disorders | Oxcarbazepine XR | 10 | 214 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Oxcarbazepine XR | 10 | 214 | |
| serious | Hypothermia | General disorders | Oxcarbazepine XR | 1 | 214 | 1 |
| serious | Spinal Fracture | Injury, poisoning and procedural complications | Oxcarbazepine XR | 1 | 214 | 1 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxcarbazepine XR | ||
| Total, other adverse events | Oxcarbazepine XR | 124 | 214 |
| Total, serious adverse events | Oxcarbazepine XR | 18 | 214 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00908349
GET https://conductscience.org/api/trials/v1/NCT00908349/events?page=2