Trial · NCT03336645
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
NCT03336645, Phase 3, Completed, Shire; results first posted 2020-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan. Trials, record NCT03336645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03336645
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
- NCT number
- NCT03336645
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Shire
- Conditions
- Nervous System Diseases
- Interventions
- SHP615
- First posted
- 2017-11-08
- Last updated
- 2020-07-31
- Results first posted
- 2020-07-31
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Response Rate | SHP615 | 80.0 | Percentage of participants | ||
| Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours | SHP615 | Sustained Absence for at least 1 hour | 68.0 | Percentage of participants | |
| Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours | SHP615 | Sustained Absence for at least 4 hours | 36.0 | Percentage of participants | |
| Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours | SHP615 | Sustained Absence for at least 6 hours | 32.0 | Percentage of participants | |
| Number of Participants With Time to Resolution of Seizures (Convulsions) | SHP615 | 21 | Participants | ||
| Number of Participants With Time to Recovery of Consciousness | SHP615 | 19 | Participants | ||
| Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) | SHP615 | 16.0 | Percentage of Participants | ||
| Percentage of Participants Who Failed to Respond to the Treatment With SHP615 | SHP615 | 16.0 | Percentage of participants | ||
| Concentration of SHP615 in Plasma at 10 Minutes (C10) | SHP615 | 45.2 | Standard Deviation 21.3 | nanogram per milliliter (ng/mL) | |
| Maximum Plasma Concentration (Cmax) of SHP615 | SHP615 | 78.0 | Standard Deviation 16.4 | ng/mL |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHP615 | 25 | |
| Overall Study | COMPLETED | SHP615 | 25 | |
| Overall Study | NOT COMPLETED | SHP615 | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Respiratory depression | Respiratory, thoracic and mediastinal disorders | SHP615 | 2 | 25 | 2 |
| serious | Seizure cluster | Nervous system disorders | SHP615 | 1 | 25 | 1 |
| serious | Status epilepticus | Nervous system disorders | SHP615 | 1 | 25 | 1 |
| serious | Respiratory depression | Respiratory, thoracic and mediastinal disorders | SHP615 | 1 | 25 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHP615 | 0 | 25 |
| Total, other adverse events | SHP615 | 2 | 25 |
| Total, serious adverse events | SHP615 | 3 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03336645
GET https://conductscience.org/api/trials/v1/NCT03336645/results?page=2