Trial · NCT02351115
Staccato Alprazolam and Photoparoxysmal Response
NCT02351115, Phase 2, Completed, Nova Pneuma Inc.; results first posted 2021-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Staccato Alprazolam and Photoparoxysmal Response. Trials, record NCT02351115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02351115
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Staccato Alprazolam and Photoparoxysmal Response
- NCT number
- NCT02351115
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Nova Pneuma Inc.
- Conditions
- Epilepsy
- Interventions
- A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m, D= Inhaled Alprazolam 2 mg, E=Placebo
- First posted
- 2015-01-30
- Last updated
- 2026-04-20
- Results first posted
- 2021-08-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) | SPR was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at: 10 min for alprazolam 2 mg, 1 hour for alprazolam 0.5 and 1 mg and placebo | Photosensitivity describes the presentation of an epileptiform EEG response (photoparoxysmal response) from exposure to intermittent photic stimulation (IPS). SPR is the number of frequency steps (2, 5, 8, 10, 13, 15, 18, 20, 23, 25, 30, 40, 50 and 60 Hz). between the upper and lower limits of sensitivity to IPS for that patient at that time, in order not to evoke seizures. Thus a reduction (-change) means the intervention is working (desired effect on sensitivity) |
| Secondary | Maximum Sedation Using Visual Analog Scale (Sedated-Alert) | Sedation was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at:: 30 min for alprazolam 1 mg, 1 hour for alprazolam 0.5 and 2 mg, and 4 hours for placebo | Maximum change (in mm) from pretreatment baseline in level of sedation reported by the patient on a 100 mm line anchored by Sedated (0) and Alert (100) |
| Secondary | Maximum Sedation Using Visual Analog Scale (Sleepy-Awake) | Sleepiness was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred: at: 30 min for alprazolam 1 mg, 1 hour for alprazolam 0.5 and 2 mg and placebo | Maximum change (in mm) from pretreatment baseline in level of sedation reported by each subject on a 100 mm line anchored by Sleepy (0) and Awake (100) |
| Secondary | Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Standardized Photosensitivity Range (SPR) | Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration | Pearson correlation of all paired plasma concentrations of alprazolam (PK) with pharmacodynamic effect on SPR (PD) for each alprazolam dose |
| Secondary | Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Visual Analog Scale (Sedated-Alert) | Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration | Pearson correlation of all paired plasma concentrations of alprazolam (PK) with pharmacodynamic effect on Sedation (PD) for each alprazolam dose |
| Secondary | Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Visual Analog Scale (Sleepy-Awake) | Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration | Pearson correlation of all paired plasma concentrations of alprazolam (PK) with pharmacodynamic effect on Sleepiness (PD) for each alprazolam dose |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) | SPR was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at: 10 min for alprazolam 2 mg, 1 hour for alprazolam 0.5 and 1 mg and placebo | All 5 patients received all 4 treatments (crossover design) | Number of frequency steps | MEAN |
| SECONDARY | Maximum Sedation Using Visual Analog Scale (Sedated-Alert) | Sedation was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at:: 30 min for alprazolam 1 mg, 1 hour for alprazolam 0.5 and 2 mg, and 4 hours for placebo | All 5 patients received each of the 4 treatments after washout (crossover design) | units on a scale | MEAN |
| SECONDARY | Maximum Sedation Using Visual Analog Scale (Sleepy-Awake) | Sleepiness was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred: at: 30 min for alprazolam 1 mg, 1 hour for alprazolam 0.5 and 2 mg and placebo | All 5 patients received each of the 4 treatments after washout (crossover design) | units on a scale | MEAN |
| SECONDARY | Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Standardized Photosensitivity Range (SPR) | Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration | PK-PD population pairs, All 5 crossover subjects by alprazolam treatment received~Number of PK-PD pairs per dose (n) = 35 (7 time points x 5 subjects) | correlation coefficient | MEAN |
| SECONDARY | Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Visual Analog Scale (Sedated-Alert) | Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration | PK-PD population pairs, All 5 crossover subjects by alprazolam treatment received~Number of PK-PD pairs per dose (n) = 35 (7 time points x 5 subjects) | correlation coefficient | MEAN |
| SECONDARY | Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Visual Analog Scale (Sleepy-Awake) | Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration | PK-PD population pairs, All 5 crossover subjects by alprazolam treatment received~Number of PK-PD pairs per dose (n) = 35 (7 time points x 5 subjects) | correlation coefficient | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) | Inhaled Placebo | -0.2 | 90% Confidence Interval -1.87 to 1.47 | Number of frequency steps | |
| Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) | Staccato Alprazolam, 0.5 mg | -4.4 | 90% Confidence Interval -6.98 to -1.82 | Number of frequency steps | |
| Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) | Staccato Alprazolam, 1 mg | -5.2 | 90% Confidence Interval -7.85 to -2.55 | Number of frequency steps | |
| Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) | Staccato Alprazolam, 2 mg | -4.8 | 90% Confidence Interval -7.99 to -1.61 | Number of frequency steps | |
| Maximum Sedation Using Visual Analog Scale (Sedated-Alert) | Inhaled Placebo | -5.3 | 90% Confidence Interval -23.84 to 13.34 | units on a scale | |
| Maximum Sedation Using Visual Analog Scale (Sedated-Alert) | Staccato Alprazolam, 0.5 mg | -58 | 90% Confidence Interval -82.77 to -33.23 | units on a scale | |
| Maximum Sedation Using Visual Analog Scale (Sedated-Alert) | Staccato Alprazolam, 1 mg | -67.4 | 90% Confidence Interval -87.47 to -47.33 | units on a scale | |
| Maximum Sedation Using Visual Analog Scale (Sedated-Alert) | Staccato Alprazolam, 2 mg | -70.6 | 90% Confidence Interval -94.06 to -47.14 | units on a scale | |
| Maximum Sedation Using Visual Analog Scale (Sleepy-Awake) | Inhaled Placebo | -9.2 | 90% Confidence Interval -26.33 to 7.93 | units on a scale | |
| Maximum Sedation Using Visual Analog Scale (Sleepy-Awake) | Staccato Alprazolam, 0.5 mg | -54 | 90% Confidence Interval -72.59 to -35.31 | units on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BEADC | 1 | |
| Overall Study | STARTED | CDAEB | 1 | |
| Overall Study | STARTED | DEBAC | 1 | |
| Overall Study | STARTED | EDBAC | 1 | |
| Overall Study | STARTED | CABED | 1 | |
| Overall Study | COMPLETED | BEADC | 1 | |
| Overall Study | COMPLETED | CDAEB | 1 | |
| Overall Study | COMPLETED | DEBAC | 1 | |
| Overall Study | COMPLETED | EDBAC | 1 | |
| Overall Study | COMPLETED | CABED | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events92
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 | Eye irritation | Eye disorders | Inhaled Placebo | 1 | 5 | 1 |
| other | Eye irritation | Eye disorders | Staccato® Alprazolam, 0.5 mg | 0 | 5 | 0 |
| other | Eye irritation | Eye disorders | Staccato® Alprazolam, 1 mg | 0 | 5 | 0 |
| other | Eye irritation | Eye disorders | Staccato® Alprazolam, 2 mg | 0 | 5 | 0 |
| other | Lacrimation increased | Eye disorders | Inhaled Placebo | 0 | 5 | 0 |
| other | Lacrimation increased | Eye disorders | Staccato® Alprazolam, 0.5 mg | 1 | 5 | 1 |
| other | Lacrimation increased | Eye disorders | Staccato® Alprazolam, 1 mg | 1 | 5 | 1 |
| other | Lacrimation increased | Eye disorders | Staccato® Alprazolam, 2 mg | 1 | 5 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Inhaled Placebo | 0 | 5 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Staccato® Alprazolam, 0.5 mg | 1 | 5 | 1 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Placebo | 0 | 5 |
| Total, all-cause mortality | Staccato® Alprazolam, 0.5 mg | 0 | 5 |
| Total, all-cause mortality | Staccato® Alprazolam, 1 mg | 0 | 5 |
| Total, all-cause mortality | Staccato® Alprazolam, 2 mg | 0 | 5 |
| Total, other adverse events | Inhaled Placebo | 2 | 5 |
| Total, other adverse events | Staccato® Alprazolam, 0.5 mg | 2 | 5 |
| Total, other adverse events | Staccato® Alprazolam, 1 mg | 3 | 5 |
| Total, other adverse events | Staccato® Alprazolam, 2 mg | 4 | 5 |
| Total, serious adverse events | Inhaled Placebo | 0 | 5 |
| Total, serious adverse events | Staccato® Alprazolam, 0.5 mg | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT02351115
GET https://conductscience.org/api/trials/v1/NCT02351115/results?page=2