Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04251910 | Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia | PHASE1 | COMPLETED | 100 | — | — | Dec 27, 2019 | Jan 24, 2022 | Jun 3, 2026 | 5 | United States |
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.
The safety and tolerability of single doses of BXCL501 was determined in treatment of acute agitation associated with dementia.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Part B Cohort | ACTIVE_COMPARATOR | Part B cohort consists 46 subjects receiving 40 Micrograms or placebo |
| Name | Type | Description |
|---|---|---|
| Sublingual film containing Dexmedetomidine | DRUG | Sublingual film containing Dexmedetomidine |
| Sublingual Placebo Film | DRUG | Sublingual placebo film that matches BXCL501 |
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 cr...