NCT04251910|CompletedPhase 1ResultsFDA Drug

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

TRANQUILITY

A Phase Ib/II, Multicenter, Randomized, Double Blind, Placebo Controlled, Ascending Dose Finding, Efficacy, Pharmacokinetic and Safety Study of BXCL501 In Agitation Associated With Dementia

BioXcel Therapeutics Inc ClinicalTrials.gov

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1 other identifier

BXCL501-103

Study Type

interventional

Target

100

Locations

1 country

Sites

Timeline

RegisteredFeb 2020

StartedDec 2019

CompletionJan 2022

Brief Summary

This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Dec 2019

Typical duration for phase_1

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

December 27, 2019

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed

Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

January 28, 2020

Results QC Date

August 1, 2023

Last Update Submit

August 28, 2023

Conditions

Agitation,Psychomotor Dementia

Outcome Measures

Primary Outcomes (2)

Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score
The change in PEC score was evaluated at 2 hours following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
Baseline and 2 hours post-dose
Number of Patients With Adverse Events
The safety and tolerability of single doses of BXCL501 was determined in treatment of acute agitation associated with dementia.
Day 7 post dose

Secondary Outcomes (10)

Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
Baseline and at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, Day 3, Day 7 post-dose
Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline
Baseline and 1 hour, 2 hours, 4 hours, 8 hours post-dose
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
Baseline and at 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, Day 3 and Day 7 post-dose
Number of Patients at Each Dose Who Achieve a 40% Reduction From Baseline in PEC Total Score at 2 Hours Post-dose ("Responders")
Baseline and 2 hours post-dose
Change in Clinician Global Impression of Severity (CGI-S) Agitation Score From Baseline
Baseline and at 2 hours, and 24 hours post-dose
+5 more secondary outcomes

Study Arms (4)

Cohort 1- 30 Micrograms

ACTIVE COMPARATOR

Cohort 1 consists of 10 patients out of whom 8 patients receive 30 Micrograms film and the remaining 2 patients receive a placebo

Drug: Sublingual film containing DexmedetomidineDrug: Sublingual Placebo Film

Cohort 2- 60 Micrograms

ACTIVE COMPARATOR

Cohort 2 consists of 10 patients out of whom 8 patients receive 60 Micrograms film and the remaining 2 patients receive a placebo. Additional 20 subjects receive 60 Micrograms or placebo.

Drug: Sublingual film containing DexmedetomidineDrug: Sublingual Placebo Film

Cohort 3- 90 Micrograms

ACTIVE COMPARATOR

Cohort 3 consists of 10 patients out of whom 8 patients receive 90 Micrograms film and the remaining 2 patients receive a placebo

Drug: Sublingual film containing DexmedetomidineDrug: Sublingual Placebo Film

Part B Cohort

ACTIVE COMPARATOR

Part B cohort consists 46 subjects receiving 40 Micrograms or placebo

Drug: Sublingual film containing DexmedetomidineDrug: Sublingual Placebo Film

Interventions

Sublingual film containing DexmedetomidineDRUG

Sublingual film containing Dexmedetomidine

Also known as: BXCL501

Cohort 1- 30 MicrogramsCohort 2- 60 MicrogramsCohort 3- 90 MicrogramsPart B Cohort

Sublingual Placebo FilmDRUG

Sublingual placebo film that matches BXCL501

Cohort 1- 30 MicrogramsCohort 2- 60 MicrogramsCohort 3- 90 MicrogramsPart B Cohort

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Male and female patients 65 years and older.
Patients who have dementia and a history of acute agitation.
History of agitation that requires intervention or impairs social or daily activities
Patients who meet International Psychogeriatric Association (IPA) diagnostic criterion for agitation.
Patients with a total score of ≥ 8 on the Pittsburgh Agitation Scale (PAS).
Patients who have a score of ≥ 2 on at least 1 of the 4 items on the Pittsburgh Agitation Scale (PAS).
Patients who read, understand and provide written informed consent, or who have a Legally Authorized Representative (LAR).
Patients who are in good general health.

You may not qualify if:

For Part B: Patients with dementia associated with Parkinson's disease and/or Lewy Body Disease, if etiology of dementia is known.
Patients with agitation caused by acute intoxication.
Patients treated within 4 hours prior to study drug administration with benzodiazepines, other sedatives, hypnotics or oral or short-acting intramuscular antipsychotics must be excluded.
Treatment with alpha-1 noradrenergic blockers, alpha adrenergic antagonists within 8 hours prior to dosing.
No new chronic medications initiated in the past 14 days prior to screening excluding over-the-counter products taken sporadically.
Patients at significant risk of harm to themselves or others
Patients considered medically unstable or in recovery
Patients with history of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension.
Cohort 3 only: Patients who are taking nitrates or beta blockers shall be excluded. Any other anti-hypertensives should be maintained in the course of the study.
Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
Patients experiencing clinically significant pain, per Investigator.
Cohort 3 only: Patients who are a high fall risk assessed via the Johns Hopkins Fall Risk Assessment (total score \>13) or during the 1-week safety observation period
Pregnancy

Contact the study team to confirm eligibility.