NCT07550881: Phase 2 Intranasal Dexmedetomidine for Acute Anxiety
ClinicalTrials.gov Studies
Summary
NCT07550881 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating the efficacy and safety of dexmedetomidine hydrochloride nasal spray (30 μg) in treating acute anxiety in adults. The study enrolled participants meeting acute anxiety criteria, randomized 1:1 to active drug or placebo, with assessments at baseline and multiple post-administration intervals (15, 30, 45, 60, 90, and 120 minutes) measuring subjective anxiety severity, clinician-rated scales, vital signs, and biological markers. Adverse events are monitored during a 7-day follow-up period. The trial was registered with an anticipated completion date of April 24, 2026.
“This study employs a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray in the treatment of acute anxiety in adults.”
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What changed
NCT07550881 registers a Phase 2 clinical trial for intranasal dexmedetomidine in acute anxiety. The trial employs a randomized, double-blind, placebo-controlled design with a 1:1 randomization ratio. Participants receive either 30 μg dexmedetomidine nasal spray or equal-volume placebo, with efficacy and safety assessed via multiple validated scales including NRS, STAI-S-6, CGI-S, CGI-I, and RASS at defined intervals. Vital signs and biological markers are collected at baseline and follow-up visits, with a 7-day adverse event monitoring period.
For sponsors and clinical investigators, this trial represents a potential new therapeutic approach for acute anxiety using a non-invasive nasal delivery formulation. Pharmaceutical manufacturers developing CNS compounds may monitor enrollment progress and endpoints for signals on dosing optimization and clinical efficacy that could inform competitive pipeline positioning.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Intranasal Dexmedetomidine for Acute Anxiety State in Adults: A Randomized Trial
Phase 2 NCT07550881 Kind: PHASE2 Apr 24, 2026
Abstract
This study employs a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray in the treatment of acute anxiety in adults.
Study Protocol: Patients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study. Upon enrollment, baseline assessments were conducted to evaluate the number of accompanying symptoms, subjective anxiety severity (NRS), STAI-S-6, CGI-S, and RASS. Immediately following these assessments, patients received a nasal spray of 30 μg of dexmedetomidine or an equal-volume placebo; the time of administration was recorded as 0 minutes. At 15, 30, 45, 60, 90, and 120 minutes post-administration, the NRS for subjective anxiety severity, CGI-S, and CGI-I were assessed. The count of accompanying symptoms, STAI-S-6, and RASS were re-assessed only at 15, 30, and 120 minutes post-administration. In addition, vital signs (heart rate, oxygen saturation, and blood pressure) were assessed and recorded at baseline (prior to administration) and at 15, 30, 45, 60, 90, and 120 minutes post-administration. Venous blood samples were collected prior to administration and 90-120 minutes post-administration to measure biological markers. Adverse events were monitored during a 7-day follow-up period after treatment.
Conditions: Acute Anxiety States
Interventions: Dexmedetomidine
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