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Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

NCT05271552 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-12-31

Study results available
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Summary

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[PRN\]), for a maximum of 28 doses within a 12-week treatment period.

Conditions

Interventions

DRUG

BXCL501

Sublingual Film

DRUG

Matching Placebo

Sublingual Placebo Film

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Robert Risinger, MD · BioXcel Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2023-04-21
Completion
2023-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271552 on ClinicalTrials.gov