Trial · NCT03336645
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Response Rate | From start of study drug administration up to 30 minutes post-dose | Response rate was defined as the percentage of participants with therapeutic success. Therapeutic success was defined as the cessation of visible seizure activity within 10 minutes with a sustained absence of visible seizure activity for 30 minutes following a single dose of MHOS/SHP615 without the need for additional rescue medication. |
| Secondary | Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours | From start of study drug administration up to 1, 4 and 6 hours post-dose | Percentage of participants whose seizure event stopped within 10 minutes of single dose administration of SHP615 and who had sustained absence of seizure activity for at least 1, 4, and 6 hours were reported. |
| Secondary | Number of Participants With Time to Resolution of Seizures (Convulsions) | From start of study drug administration up to follow-up (Day 8) | Time to resolution of seizures (convulsions) was calculated as time from IP administration to the end of the initial seizure or administration of rescue anti-convulsant medication, whichever occurs first. Initial seizure referred to the seizure that triggered the use of the IP. Number of participants with time to resolution of seizures (convulsions) from the administration of SHP615 were reported. |
| Secondary | Number of Participants With Time to Recovery of Consciousness | From start of study drug administration up to follow-up (Day 8) | Time to recovery of consciousness (in minutes) was calculated only for participants who lost consciousness pre-dose at time from investigational product administration to recovery of consciousness post-dose or administration of rescue anticonvulsant medication, whichever occurs first. Number of participants with time to recovery of consciousness were reported. |
| Secondary | Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) | 10 minutes post-dose | Percentage of participants who required additional anticonvulsant medication for ongoing SE, 10 minutes after a single dose of SHP615 were reported. |
| Secondary | Percentage of Participants Who Failed to Respond to the Treatment With SHP615 | 10 minutes post-dose | Treatment failure/non-responder was defined as participants with continuing seizure activity and/or the need for any additional rescue medication according to the participating healthcare setting protocol or guideline, for 10 mins or more after a single dose of the IP. |
| Secondary | Concentration of SHP615 in Plasma at 10 Minutes (C10) | 10 minutes post-dose | Concentration of SHP615 in plasma at 10 minutes were reported. |
| Secondary | Maximum Plasma Concentration (Cmax) of SHP615 | 1, 3, 6 hours post-dose | Cmax of SHP615 in plasma were reported. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to 10 Minutes (AUC0-10) of SHP615 in Plasma | Pre-dose, 10 minutes post-dose | AUC0-10 of SHP615 in plasma were reported. Here "min ng/mL" was minutes nanogram per milliliter. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to 60 Minutes (AUC0-60) of SHP615 in Plasma | Pre-dose, 60 minutes post-dose | AUC0-60 of SHP615 in plasma were reported. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to 180 Minutes (AUC0-180) of SHP615 in Plasma | Pre-dose, 180 minutes post-dose | AUC0-180 of SHP615 in plasma were reported. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of SHP615 in Plasma | Pre-dose, 1, 3, and 6 hours post-dose | AUC(0-infinity) of SHP615 in plasma were reported. |
| Secondary | Time at Maximum Concentration (Tmax) of SHP615 in Plasma | 1, 3, and 6 hours post-dose | Tmax of SHP615 in plasma were reported. |
| Secondary | Elimination Half-life (T1/2) of SHP615 in Plasma | 1, 3, and 6 hours post-dose | T1/2 of SHP615 in plasma were reported. |
| Secondary | Number of Participants With Respiratory Depression | From start of study drug administration up to follow-up (Day 8) | Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to \< 92 percent (%) measured at 10, 30 minutes, and 4, 6, and 24 hours post-dose (i.e, \< 92 % on room air for 2 minutes or more after dosing while monitoring \[per healthcare setting protocol and/or the clinical judgment of the physician\]) ii) Increase in respiratory effort such that assisted ventilation is used (bag-valve-mask ventilation or endotracheal intubation). Number of participants with respiratory depression were reported. |
| Secondary | Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Day 8) | TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of IP. Number of participants with aspiration pneumonia identified as TEAEs were reported. |
| Secondary | Change From Baseline in Riker Sedation-Agitation Scale at 24 Hours Post-dose | Baseline, 24 hours post-dose | Sedation-Agitation was assessed, using the "Riker Sedation-Agitation Scale" (SAS) by the following 7-point scale: 7. dangerous agitation; 6. very agitated; 5. agitated; 4. calm, cooperative; 3. sedated; 2. very sedated; 1. unarousable. Change from baseline in riker sedation-agition scale at 24 hours post-dose were reported. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Day 8) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of IP. Number of participants with TEAEs were reported. |
| Secondary | Change From Baseline in Oxygen Saturation Percentage at 24 Hours Post-dose | Baseline, 24 hours post-dose | Oxygen saturation at baseline was measured and recorded on room air. The investigator had recorded the oxygen saturation, oxygen delivery system and amount of oxygen administered during the study. Change from baseline in oxygen saturation percentage at 24 hours post-dose were reported. |
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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