Trial · NCT00280059
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase | Week 5 up to Week 56 | Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study. | percentage of participants | NUMBER |
| SECONDARY | Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. | days | MEDIAN |
| SECONDARY | Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Week 0 to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) | Week 0 to Week 56 | FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Exit Due to Any Reason After 4-week Dose Escalation Phase | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500. | participants | NUMBER |
| SECONDARY | Time to First Seizure After the 4-Week Dose Escalation Phase | Week 4 up to Week 56 | FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. | days | MEDIAN |
| SECONDARY | Median Monthy Seizure Frequency: All Partial Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEDIAN |
| SECONDARY | Mean Monthy Seizure Frequency: All Partial Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEAN |
| SECONDARY | Median Monthy Seizure Frequency: All Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEDIAN |
| SECONDARY | Mean Monthy Seizure Frequency: All Seizures | Baseline up to Week 60 | FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation. | seizures/28 days | MEAN |
| SECONDARY | Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures | Month 1 through Month 9 (after 6 months seizure freedom achieved) | FAS. N = number of responders; n = number of responders with analyzable data at observation. | seizures/28 days | MEDIAN |
| SECONDARY | Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures | Month 1 through Month 9 (after 6 months seizure freedom achieved) | FAS. N = number of responders; n = number of responders with analyzable data at observation. | 28-day seizure rate | MEAN |
| SECONDARY | Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures | Month 1 through Month 9 (after 6 months seizure freedom achieved) | FAS. N = number of responders; n = number of responders with analyzable data at observation. | seizures/28 days | MEDIAN |
| SECONDARY | Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures | Month 1 through Month 9 (after 6 months seizure freedom achieved) | FAS. N = number of responders; n = number of responders with analyzable data at observation. | 28-day seizure rate | MEAN |
| SECONDARY | Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group | Week 5 up to Week 56 | FAS; N = number of participants with analyzable data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS) | Baseline to Week 56 | FAS; N = number of participants with a HADS measurement at baseline and Week 56. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale | Week 8, Week 32, and Week 56 | FAS | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00280059/outcomes