Nervous System DiseasesPhase 3NCT03336450
Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
A Phase 3 study testing SHP615 and MHOS/SHP615 in people with Nervous System Diseases, run by Shire at 23 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 216 months
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- SHP615 and MHOS/SHP615
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 23 sitesJapan
- Study dates
- 23 Apr 2018to 13 Oct 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 216 months
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 (<) 18 years of age at the time of investigational product administration. If the subject's exact age is not known, the subject should be excluded.
- Parent, guardian, or legally authorized representative of the child who provides informed consent and assent (when applicable) to participate in the study after initial stabilization of the subject with SE in hospital or emergency room during the SHP615-301 study. The subject also provides informed consent prior to participation, where applicable.
- Parent, guardian, or legally authorized representative who have received appropriate training/education and are deemed qualified by the investigator and are willing to:
- Properly administer MHOS/SHP615.
- Record seizure information and dosing of MHOS/SHP615 in a subject diary (including time of seizure onset, type of seizure, time necessary to administer MHOS/SHP615, time between MHOS/SHP615 administration to seizure cessation, etc.)
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- Follow the necessary instructions to secure the safety of the subject.
- Subjects who experience generalized tonic-clonic SE with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration:
- Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour
- Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness.
- Currently presenting with a single seizure (convulsive) persisting greater than or equal to (>=) 5 minutes.
Who cannot join
- 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
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- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Japan23 sites
Fukuoka Children's Hospital(NW)
Fukuoka, 813-0017
Gifu Prefectural General Medical Center
Gifu, 500-8717
NHO Hokkaido Medical Center
Hokkaidō, 063-0005
Yamanashi Prefectural Central Hospital
Kofu, Fujimi, 400-8506
Kumamoto Saishunso National Hospital
Kumamoto, 861-1196
NHO Nagasaki Medical Center
Nagasaki, 856-8562
NHO Nishi Niigata Chuo National Hospital
Niigata, 950-2085
Aichi Children's Health and Medical Center(NW)
Ōbu, 474-8710
NHO Minami-Okayama Medical Center
Okayama, Okayama-ken, 701-0304
Okayama University Hospital
Okayama, 700-0914
Nakano Children's Hospital
Osaka, 535-0022
Osaka Women's and Children's Hospital(NW)
Osaka, 594-1101
Saitama Children's Medical Center(NW)
Saitama, 330-8777
Jichi Children's Medical Center Tochigi
Saitama-shi, 330-8503
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-8688
Osaka University Hospital
Suita, 565-0871
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
National Center Hospital, NCNP
Tokyo, 187-0031
Tottori University Hospital
Tottori, 683-8504
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo, Owada Shinden, 276-8524
Osaka University Hospital
Yamadaoka, 565-0871
Kanagawa Children's Medical Center(NW)
Yokohama, 232-0066
About this study
Official title: A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in Community Settings
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.
- Conditions
- Nervous System Diseases
- Being tested
- SHP615, MHOS/SHP615
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHP615Drug
Also called MHOS, Midazolam hydrochloride oromucosal solution
SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).
MHOS/SHP615Drug
MHOS/SHP615
| Study group | Role | What they receive |
|---|---|---|
| SHP615 | Experimental | Participants will receive a single age-specific dose (approximately 0.25 to 0.5 milligram per kilogram [mg/kg] as midazolam) of SHP615 oromucosal solution through buccal route upon onset of seizures. Receives: Drug: SHP615; Drug: MHOS/SHP615 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Number of Participants With Therapeutic Success
Therapeutic success was defined as cessation of visible seizure activity within 10 minutes and sustained absence of visible seizure activity for 30 minutes following a single dose of SHP615 without the need for additional rescue medication. Number of participants with therapeutic success were reported.
Measured: From start of study drug administration up to 30 minutes post-dose
Safety: Number of Participants With Respiratory Depression
Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to <92 percent (%) measured up to 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.
Measured: Up to 24 hours post-dose
Secondary outcomes (13)
Efficacy: Number of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4, and 6 Hours
Number 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.
Measured: From start of study drug administration up to 1, 4, and 6 hours post-dose
Efficacy: Time to Resolution of Seizures (Convulsions)
Time to resolution of seizures (convulsions) was calculated as time from SHP615 administration to the end of the initial seizure or administration of rescue anticonvulsant medication, whichever occurs first. The initial seizure refers to the seizure which triggered the use of the IP. Participant wise data was reported for this outcome.
Measured: From start of study drug administration up to follow-up (Day 8)
Efficacy: Time to Recovery of Consciousness
Time to recovery of consciousness in minutes was calculated only for participants who lost consciousness pre-dose as time from SHP615 administration to recovery of consciousness post-dose or administration of rescue anticonvulsant medication, whichever occurs first. Participant wise data was reported for this outcome.
Measured: From start of study drug administration up to follow-up (Day 8)
Efficacy: Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) 10 Minutes After Administration of SHP615
Percentage of participants who required additional anticonvulsant medication for ongoing SE according to the participating hospital protocol or guideline, 10 minutes after the administration of SHP615 were reported.
Measured: 10 minutes post-dose
Efficacy: Percentage of Participants Who Failed to Respond to Treatment With SHP615
Treatment failure/non-responder was defined as continuing seizure activity and/or the need for any additional rescue medication according to the participating healthcare setting protocol or guideline 10 minutes after administration of SHP615 was reported.
Measured: 10 minutes post-dose
Safety: Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs)
TEAEs was defined as adverse events (AEs) whose onset occurs, severity worsens or intensity increases on or after the date of SHP615 administration. Number of participants with aspiration pneumonia identified as TEAEs were reported.
Measured: From start of study drug administration up to follow-up (Day 8)
Safety: Number of Participants Analyzed for Sedation or Agitation Measured by the Riker Sedation-Agitation Scale
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. Number of participants analyzed for sedation or agitation measured by the riker sedation-agitation scale were reported.
Measured: 1, 4, 6, and 24 hours post-dose
Safety: Number of Participants With Buccal Irritation Reported as Treatment Emergent Adverse Events (TEAEs)
TEAEs was defined as AEs whose onset occurs, severity worsens or intensity increases on or after the date of IP administration. Buccal cavity was examined for redness, inflammation and ulceration. Number of participants with buccal irritation reported as TEAEs were reported.
Measured: Up to 6 hours post-dose
Safety: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An 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 whose onset occurs, severity worsens or intensity increases on or after the date of IP administration. Number of participants with TEAEs were reported.
Measured: From start of study drug administration up to follow-up (Day 8)
Safety: Number of Participants With Clinically Significant Change in Vital Signs Reported as TEAEs
Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any change in vital signs which were deemed clinically significant by the investigator were recorded as TEAEs.
Measured: From start of study drug administration up to 24 hours post-dose
Safety: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as TEAEs
Clinical laboratory evaluations included biochemistry, endocrinology, hematology and urinalysis. Any change in clinical laboratory abnormalities which were deemed clinically significant by the investigator were recorded as TEAEs.
Measured: From start of study drug administration up to 24 hours post-dose
Safety: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as TEAEs
12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAEs.
Measured: From start of study drug administration up to 24 hours post-dose
Safety: Percentage of Participants With Normal Oxygen Saturation Values Collected During Hospital Setting
Oxygen saturation is the amount of oxygen that is in bloodstream and is measured as the percentage of blood hemoglobin that is carrying oxygen. Normal oxygen saturation levels are considered to be 95-100 percent; low oxygen saturation values indicate worse disease. Oxygen saturation was measured and recorded on room air. The investigator recorded the oxygen saturation as well as the oxygen delivery system and amount of oxygen administered during hospital setting. Percentage of participants with normal oxygen saturation values collected during hospital setting were reported.
Measured: 0.5, 1, 4, 6 and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start23 Apr 2018
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda Development Center Americas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336450
- Sponsor's protocol ID
- SHP615-302
- Status last verified
- Aug 2021
- First submitted
- 6 Nov 2017
- Last updated
- 14 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in Community Settings
- ClinicalTrials.gov ID
- NCT03336450
- Acronym / sponsor ID
- SHP615-302
- Conditions
- Nervous System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHP615 | Experimental | Drug: SHP615, Drug: MHOS/SHP615Participants will receive a single age-specific dose (approximately 0.25 to 0.5 milligram per kilogram [mg/kg] as midazolam) of SHP615 oromucosal solution through buccal route upon onset of seizures. |
Who may qualify
- Ages
- 6 to 216 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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 (<) 18 years of age at the time of investigational product administration. If the subject's exact age is not known, the subject should be excluded.
- Parent, guardian, or legally authorized representative of the child who provides informed consent and assent (when applicable) to participate in the study after initial stabilization of the subject with SE in hospital or emergency room during the SHP615-301 study. The subject also provides informed consent prior to participation, where applicable.
- Parent, guardian, or legally authorized representative who have received appropriate training/education and are deemed qualified by the investigator and are willing to:
- Subjects who experience generalized tonic-clonic SE with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHP615Also: MHOS, Midazolam hydrochloride oromucosal solutionSHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg). | Drug | SHP615 |
| MHOS/SHP615MHOS/SHP615 | Drug | SHP615 |
Primary outcome
Efficacy: Number of Participants With Therapeutic Success
Time frame: From start of study drug administration up to 30 minutes post-dose
Therapeutic success was defined as cessation of visible seizure activity within 10 minutes and sustained absence of visible seizure activity for 30 minutes following a single dose of SHP615 without the need for additional rescue medication. Number of participants with therapeutic success were reported.
Safety: Number of Participants With Respiratory Depression
Time frame: Up to 24 hours post-dose
Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to <92 percent (%) measured up to 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.
13 secondary outcomes
Efficacy: Number of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4, and 6 Hours
Time frame: From start of study drug administration up to 1, 4, and 6 hours post-dose
Efficacy: Time to Resolution of Seizures (Convulsions)
Time frame: From start of study drug administration up to follow-up (Day 8)
Efficacy: Time to Recovery of Consciousness
Time frame: From start of study drug administration up to follow-up (Day 8)
Efficacy: Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) 10 Minutes After Administration of SHP615
Time frame: 10 minutes post-dose
Efficacy: Percentage of Participants Who Failed to Respond to Treatment With SHP615
Time frame: 10 minutes post-dose
Safety: Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to follow-up (Day 8)
Safety: Number of Participants Analyzed for Sedation or Agitation Measured by the Riker Sedation-Agitation Scale
Time frame: 1, 4, 6, and 24 hours post-dose
Safety: Number of Participants With Buccal Irritation Reported as Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 6 hours post-dose
Safety: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to follow-up (Day 8)
Safety: Number of Participants With Clinically Significant Change in Vital Signs Reported as TEAEs
Time frame: From start of study drug administration up to 24 hours post-dose
Safety: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as TEAEs
Time frame: From start of study drug administration up to 24 hours post-dose
Safety: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as TEAEs
Time frame: From start of study drug administration up to 24 hours post-dose
Safety: Percentage of Participants With Normal Oxygen Saturation Values Collected During Hospital Setting
Time frame: 0.5, 1, 4, 6 and 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda Development Center Americas
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHP615 and MHOS/SHP615 in people with Nervous System Diseases, run by Shire at 23 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Number of Participants With Therapeutic Success (time frame: From start of study drug administration up to 30 minutes post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.