Trial · NCT03336645
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Response Rate | From start of study drug administration up to 30 minutes post-dose | Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP. | Percentage of participants | NUMBER |
| 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 | FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Time to Resolution of Seizures (Convulsions) | From start of study drug administration up to follow-up (Day 8) | FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to Recovery of Consciousness | From start of study drug administration up to follow-up (Day 8) | FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) | 10 minutes post-dose | FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Failed to Respond to the Treatment With SHP615 | 10 minutes post-dose | FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP. | Percentage of participants | NUMBER |
| SECONDARY | Concentration of SHP615 in Plasma at 10 Minutes (C10) | 10 minutes post-dose | Pharmacokinetic (PK) set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of SHP615 | 1, 3, 6 hours post-dose | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | ng/mL | MEAN |
| 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 | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | min ng/mL | MEAN |
| 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 | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | min ng/mL | MEAN |
| 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 | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | min ng/mL | MEAN |
| 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 | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | min ng/mL | MEAN |
| SECONDARY | Time at Maximum Concentration (Tmax) of SHP615 in Plasma | 1, 3, and 6 hours post-dose | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | minutes | MEDIAN |
| SECONDARY | Elimination Half-life (T1/2) of SHP615 in Plasma | 1, 3, and 6 hours post-dose | PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | minutes | MEDIAN |
| SECONDARY | Number of Participants With Respiratory Depression | From start of study drug administration up to follow-up (Day 8) | Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Riker Sedation-Agitation Scale at 24 Hours Post-dose | Baseline, 24 hours post-dose | Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | Score on the scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Day 8) | Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Oxygen Saturation Percentage at 24 Hours Post-dose | Baseline, 24 hours post-dose | Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. Here, the number of participants analyzed refer to the participants evaluable for this outcome. | Percentage of oxygen saturation | MEAN |
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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