NCT04276883|CompletedPhase 3ResultsDMCFDA Drug

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

SERENITY II

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder

BioXcel Therapeutics Inc ClinicalTrials.gov

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1 other identifier

BXCL501-302

Study Type

interventional

Target

380

Locations

1 country

Sites

Timeline

RegisteredFeb 2020

StartedFeb 2020

CompletionMay 2020

Brief Summary

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.

Trial Health

On Track

Trial Health Score

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

Enrollment

380

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2020

Shorter than P25 for phase_3

Geographic Reach

1 country

15 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

February 18, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed

5 days until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed

3.3 years until next milestone

Results Posted

Study results publicly available

September 11, 2023

Completed

Last Updated

September 11, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

February 18, 2020

Results QC Date

August 8, 2023

Last Update Submit

August 30, 2023

Conditions

Agitation Associated With Bipolar Disorder Agitation,Psychomotor Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
Baseline and 120 minutes

Secondary Outcomes (1)

Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Baseline and 20, 30, 45, 60, 90, 120 minutes post-dose

Study Arms (3)

120 Micrograms

EXPERIMENTAL

Sublingual film containing 120 Micrograms Dexmedetomidine

Drug: Sublingual film containing Dexmedetomidine (BXCL501)

180 Micrograms

EXPERIMENTAL

Sublingual film containing 180 Micrograms Dexmedetomidine

Drug: Sublingual film containing Dexmedetomidine (BXCL501)

Placebo

PLACEBO COMPARATOR

Sublingual placebo film

Drug: Placebo Film

Interventions

Sublingual film containing Dexmedetomidine (BXCL501)DRUG

Sublingual film containing Dexmedetomidine (BXCL501)

Also known as: Dexmedetomidine

120 Micrograms180 Micrograms

Placebo FilmDRUG

Placebo Film for BXCL501

Also known as: Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for bipolar I or II disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

You may not qualify if:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide.
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.

Contact the study team to confirm eligibility.