Trial · NCT03478982
Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
NCT03478982, Phase 2, Completed, Engage Therapeutics, Inc.; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern. Trials, record NCT03478982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03478982
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
- NCT number
- NCT03478982
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 156 participants, actual
- Lead sponsor
- Engage Therapeutics, Inc.
- Conditions
- Epilepsy
- Interventions
- Staccato Alprazolam, Placebos
- First posted
- 2018-03-27
- Last updated
- 2021-02-03
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours | 2 hours post-dosing on dosing day | Percentage of participants with onset of a predictable seizure through 2 minutes post dosing with study drug and no recurrence of seizure activity within 2 hours were reported for each treatment group based on clinical observation. |
| Secondary | Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | 6 hours post-dosing on dosing day | Severity of on study seizure episode compared to previously experienced seizures was assessed with Seizure Episode Severity Scale. It is a 5-point scale with range from 1 to 5, where 1 indicates much worse than and 5 indicates much better than. |
| Secondary | Percentage of Participants With Use of Rescue Medication | 2 hours post-dosing on dosing day | Percentage of participants with use of rescue medication to stop a seizure episode at the discretion of the principal investigator were reported. |
| Secondary | Percentage of Participants With Secondary Generalization (Evolution to a Complex Partial Seizure and/or a Generalized Tonic-Clonic Seizure) | 24 hours post-dosing on dosing day | Percentage of participants who had seizures that evolved to a complex partial seizure and/or a generalized tonic-clonic seizure were reported. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours | 2 hours post-dosing on dosing day | The Modified Intent-to-treat (mITT) population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | 6 hours post-dosing on dosing day | The mITT population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Use of Rescue Medication | 2 hours post-dosing on dosing day | The mITT population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Secondary Generalization (Evolution to a Complex Partial Seizure and/or a Generalized Tonic-Clonic Seizure) | 24 hours post-dosing on dosing day | The mITT population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 62.5 | percentage of participants | ||
| Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours | Double-blind: Placebo | 42.5 | percentage of participants | ||
| Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours | Double-blind: Staccato Alprazolam 1.0 mg | 65.8 | percentage of participants | ||
| Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours | Double-blind: Staccato Alprazolam 2.0 mg | 65.8 | percentage of participants | ||
| Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | Much worse than | 0 | percentage of participants | |
| Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | Double-blind: Placebo | Much worse than | 2.5 | percentage of participants | |
| Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | Double-blind: Staccato Alprazolam 1.0 mg | Much worse than | 0 | percentage of participants | |
| Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | Double-blind: Staccato Alprazolam 2.0 mg | Much worse than | 0 | percentage of participants | |
| Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | Worse than | 0 | percentage of participants | |
| Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale | Double-blind: Placebo | Worse than | 5.0 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 11 | |
| Overall Study | STARTED | Double-blind: Placebo | 50 | |
| Overall Study | STARTED | Double-blind: Staccato Alprazolam 1.0 mg | 47 | |
| Overall Study | STARTED | Double-blind: Staccato Alprazolam 2.0 mg | 48 | |
| Overall Study | Enrolled Participants But Not Treated | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 3 | |
| Overall Study | Enrolled Participants But Not Treated | Double-blind: Placebo | 10 | |
| Overall Study | Enrolled Participants But Not Treated | Double-blind: Staccato Alprazolam 1.0 mg | 9 | |
| Overall Study | Enrolled Participants But Not Treated | Double-blind: Staccato Alprazolam 2.0 mg | 10 | |
| Overall Study | Intent-to-treat (ITT) Population | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 8 | |
| Overall Study | Intent-to-treat (ITT) Population | Double-blind: Placebo | 40 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events188
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 | Somnolence | Nervous system disorders | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 0 | 8 | 0 |
| other | Somnolence | Nervous system disorders | Double-blind: Placebo | 1 | 40 | 1 |
| other | Somnolence | Nervous system disorders | Double-blind: Staccato Alprazolam 1.0 mg | 7 | 38 | 8 |
| other | Somnolence | Nervous system disorders | Double-blind: Staccato Alprazolam 2.0 mg | 4 | 38 | 4 |
| other | Dysgeusia | Nervous system disorders | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 0 | 8 | 0 |
| other | Dysgeusia | Nervous system disorders | Double-blind: Placebo | 1 | 40 | 1 |
| other | Dysgeusia | Nervous system disorders | Double-blind: Staccato Alprazolam 1.0 mg | 6 | 38 | 6 |
| other | Dysgeusia | Nervous system disorders | Double-blind: Staccato Alprazolam 2.0 mg | 4 | 38 | 4 |
| other | Dizziness | Nervous system disorders | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 0 | 8 | 0 |
| other | Dizziness | Nervous system disorders | Double-blind: Placebo | 2 | 40 | 2 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 0 | 8 |
| Total, all-cause mortality | Double-blind: Placebo | 0 | 40 |
| Total, all-cause mortality | Double-blind: Staccato Alprazolam 1.0 mg | 0 | 38 |
| Total, all-cause mortality | Double-blind: Staccato Alprazolam 2.0 mg | 0 | 38 |
| Total, other adverse events | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 3 | 8 |
| Total, other adverse events | Double-blind: Placebo | 10 | 40 |
| Total, other adverse events | Double-blind: Staccato Alprazolam 1.0 mg | 14 | 38 |
| Total, other adverse events | Double-blind: Staccato Alprazolam 2.0 mg | 19 | 38 |
| Total, serious adverse events | Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg) | 0 | 8 |
| Total, serious adverse events | Double-blind: Placebo | 2 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36268811 | DERIVED |
Source PubMed
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/NCT03478982
GET https://conductscience.org/api/trials/v1/NCT03478982/results?page=2