BENITIONSClinical Trial Intelligence

Staccato Alprazolam and Photoparoxysmal Response

Phase 2 Completed NCT02351115

ConditionEpilepsy
PhasePhase 2
SponsorNova Pneuma Inc.
StatusCompleted
Enrollment5 participants
InterventionsA=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m, D= Inhaled Alprazolam 2 mg, E=Placebo
Start dateJan, 2015
Completion dateJul, 2016
Results postedAug 10, 2021

Summary

The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo.

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 · Number of frequency steps

Inhaled Placebo-0.2 Number of frequency steps
Staccato Alprazolam, 0.5 mg-4.4 Number of frequency steps
Staccato Alprazolam, 1 mg-5.2 Number of frequency steps
Staccato Alprazolam, 2 mg-4.8 Number of frequency steps

Open in BENITIONS View on ClinicalTrials.gov

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