Phase 3
N=3
Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
Nervous System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03336450 ↗Enrolled (actual)
3
Serious AEs
33.3%
Results posted
Sep 2021
Primary outcome: Primary: Efficacy: Number of Participants With Therapeutic Success — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SHP615 (Drug); MHOS/SHP615 (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Number of Participants With Therapeutic Success |
3 | — |
| PRIMARY Safety: Number of Participants With Respiratory Depression |
— | — |
| SECONDARY Efficacy: Number of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4, and 6 Hours |
3; 0; 1 | — |
| SECONDARY Efficacy: Time to Resolution of Seizures (Convulsions) |
1; 2; 5 | — |
| SECONDARY Efficacy: Time to Recovery of Consciousness |
4; 143; 5 | — |
| SECONDARY Efficacy: Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) 10 Minutes After Administration of SHP615 |
— | — |
| SECONDARY Efficacy: Percentage of Participants Who Failed to Respond to Treatment With SHP615 |
— | — |
| SECONDARY Safety: Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Safety: Number of Participants Analyzed for Sedation or Agitation Measured by the Riker Sedation-Agitation Scale |
0; 1; 1; 3; 1; 0 | — |
| SECONDARY Safety: Number of Participants With Buccal Irritation Reported as Treatment Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Safety: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
2 | — |
| SECONDARY Safety: Number of Participants With Clinically Significant Change in Vital Signs Reported as TEAEs |
— | — |
| SECONDARY Safety: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as TEAEs |
— | — |
| SECONDARY Safety: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as TEAEs |
— | — |
| SECONDARY Safety: Percentage of Participants With Normal Oxygen Saturation Values Collected During Hospital Setting |
100 | — |
Summary
The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is safe and effective in children with status epilepticus (SE) (convulsive) in the community setting. This study is open-label extension for patients who completed the SHP615-301 study and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.
Eligibility Criteria
Inclusion Criteria
- Subjects who completed the SHP615-301 study and who tolerated and responded to treatment with MHOS/SHP615 in the hospital and/or emergency room, and are considered stable for discharge from the hospital.
- Subjects who are greater than (>) 6 months and less than ( =) 5 minutes.
Exclusion Criteria
- Female subjects who are pregnant, suspected to be pregnant, or nursing.
- Subjects with major trauma, not necessarily restricted to the head, as the cause of the seizure.
- Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal.
- Subjects with seizures due to illegal drug or acute alcoholic intoxication.
- Subjects with seizures of psychogenic origin.
- Subjects with seizures due to severe encephalitis or meningitis, as determined by the PI
- Subjects with known history of hypersensitivities, nonresponsiveness or contraindications to benzodiazepines (that is (ie), clinically significant respiratory depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea, glaucoma with closed angle, or use of concomitant drugs determined by the investigator to have a contraindication to the use of benzodiazepines.)
- Subjects with a known history of benzodiazepine abuse.
- Subjects who have not responded to previous administrations of midazolam systemic therapies, including MIDAFRESA and/or DORMICUM.
- Subjects who need emergent surgical intervention and general anesthesia/intubation.
- Subjects who have been receiving human immunodeficiency virus (HIV) protease inhibitors or HIV reverse transcriptase inhibitors.
- Subjects with severe cerebral anoxia (except cerebral palsy), in the judgment of the healthcare provider.
- Have used an investigational product or been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
- Subject has prior placement of a vagus nerve stimulator.
Data sourced from ClinicalTrials.gov (NCT03336450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.