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Trial · NCT03336645

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants With Response RateSHP61580.0Percentage of participants
Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 HoursSHP615Sustained Absence for at least 1 hour68.0Percentage of participants
Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 HoursSHP615Sustained Absence for at least 4 hours36.0Percentage of participants
Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 HoursSHP615Sustained Absence for at least 6 hours32.0Percentage of participants
Number of Participants With Time to Resolution of Seizures (Convulsions)SHP61521Participants
Number of Participants With Time to Recovery of ConsciousnessSHP61519Participants
Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE)SHP61516.0Percentage of Participants
Percentage of Participants Who Failed to Respond to the Treatment With SHP615SHP61516.0Percentage of participants
Concentration of SHP615 in Plasma at 10 Minutes (C10)SHP61545.2Standard Deviation 21.3nanogram per milliliter (ng/mL)
Maximum Plasma Concentration (Cmax) of SHP615SHP61578.0Standard Deviation 16.4ng/mL
Area Under the Concentration-time Curve From Time Zero to 10 Minutes (AUC0-10) of SHP615 in PlasmaSHP615304Standard Deviation 149min ng/mL
Area Under the Concentration-time Curve From Time Zero to 60 Minutes (AUC0-60) of SHP615 in PlasmaSHP6152965Standard Deviation 592min ng/mL
Area Under the Concentration-time Curve From Time Zero to 180 Minutes (AUC0-180) of SHP615 in PlasmaSHP6154411Standard Deviation 1140min ng/mL
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of SHP615 in PlasmaSHP6155847Standard Deviation 2599min ng/mL
Time at Maximum Concentration (Tmax) of SHP615 in PlasmaSHP61520.5Full Range 15.5 to 28.0minutes
Elimination Half-life (T1/2) of SHP615 in PlasmaSHP615115Full Range 90.6 to 303minutes
Number of Participants With Respiratory DepressionSHP615Persistent Decrease in Oxygen Saturation0Participants
Number of Participants With Respiratory DepressionSHP615Increase in Respiratory Effort1Participants
Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs)SHP6150Participants
Change From Baseline in Riker Sedation-Agitation Scale at 24 Hours Post-doseSHP6152.2Standard Deviation 1.23Score on the scale

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.

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