Comparison · NCT02052739-e5db5967
SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants With Treatment Response (Treatment Responders)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants With Treatment Response (Treatment Responders). Trial comparisons, record NCT02052739-e5db5967. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02052739-e5db5967
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.813 | 0.57 | 0.934 | wilson | |
| Risk in group 2 | 0.667 | 0.3 | 0.903 | wilson | |
| Risk difference, group 1 minus group 2 | 0.146 | -0.193 | 0.532 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 0.66 | 2.25 | log | |
| Odds ratio, group 1 over group 2 | 2.17 | 0.262 | 17.9 | log | |
| Number needed to treat, for one more participant with the outcome on SAGE-547 Standard Dose than on SAGE-547 High Dose | 6.86 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SAGE-547 Standard Dose | Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5. | 13 | 16 | OG000 |
| Group 2 | SAGE-547 High Dose | Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5. | 4 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Response (Treatment Responders)
- Description
A responder was defined as a participant for whom it was not required to re-initiate continuous IV third-line therapy for refractory seizure control during the administration of SAGE-547 at the maintenance dose (prior to SAGE-547 taper infusion).
- Time frame
- Up to 96 hours
- Population
Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
- NCT number
- NCT02052739
- Phases
- PHASE1, PHASE2
- Conditions
- Super-refractory Status Epilepticus
- Interventions
- SAGE-547
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Results first posted
- 2022-05-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02052739?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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