Phase 2
N=100
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
Agitation,Psychomotor · Dementia
Bottom Line
View on ClinicalTrials.gov: NCT04251910 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Sep 2023
Primary outcome: Primary: Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score — -5.4; -7.1; -2.9; -6.8 score on a scale — p=0.0813
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sublingual film containing Dexmedetomidine (Drug); Sublingual Placebo Film (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- BioXcel Therapeutics Inc
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score |
-5.4; -7.1; -2.9; -6.8; -1.8 | 0.0813 |
| PRIMARY Number of Patients With Adverse Events |
11; 14; 4; 0; 12; 2 | — |
| SECONDARY Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline |
-1.3; -1.6; -1.3; -1.3; -0.7; -2.5 | 0.9616 |
| SECONDARY Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline |
0.6; 1.1; 0.5; 1.8; 0.4; 0.9 | 0.8760 |
| SECONDARY Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline |
-2.2; -1.7; -0.6; -1.0; -1.0; -3.6 | 0.0926 |
| SECONDARY Number of Patients at Each Dose Who Achieve a 40% Reduction From Baseline in PEC Total Score at 2 Hours Post-dose ("Responders") |
4; 14; 1; 9; 2 | 0.3359 |
| SECONDARY Change in Clinician Global Impression of Severity (CGI-S) Agitation Score From Baseline |
-1.3; -2.1; -0.9; -2.2; -0.7; -1.4 | 0.0952 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Agitation Score |
3.3; 3.4; 3.5; 3.5; 3.7; 3.0 | 0.4080 |
| SECONDARY Change in Cohen Mansfield Agitation Inventory (CMAI) Total Score From Baseline |
-8.9; -14.7; 1.6; -17.9; -5.7; -5.9 | 0.0591 |
| SECONDARY Number of Patients With Event "Time Taken for Medication to Dissolve" |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part B: Change From Baseline in the Total Score of 3 Supplementary Items of Positive and Negative Syndrome Scale (PANSS) |
-3.7; -0.6 | 0.0002 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04251910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.