SERENITY I: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

• Sponsor: BioXcel Therapeutics Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04268303
• Collaborator: Cognitive Research Corporation (Industry)
• Enrollment: 381
• Locations: 15
• Arms: 3
• Actual Duration (Months): 3.4
• Patients Per Site: 25.4
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.

Condition or Disease	Intervention/Treatment	Phase
Agitation; Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Schizophreniform Disorders	Drug: Sublingual film containing dexmedetomidine (BXCL501); Drug: Placebo Film	Phase 3

Detailed Description

The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. Eligible subjects may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.

Study Design

• Study Type: Interventional
• Actual Enrollment: 381 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase III, Randomized, Double-Blind, Placebo-ControlledPhase III, Randomized, Double-Blind, Placebo-Controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-Blind, Placebo-Controlled
• Primary Purpose: Treatment
• Official Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia
• Actual Study Start Date: Jan 24, 2020
• Actual Primary Completion Date: May 6, 2020
• Actual Study Completion Date: May 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 120 Micrograms Sublingual film containing 120 Micrograms dexmedetomidine	Drug: Sublingual film containing dexmedetomidine (BXCL501); Sublingual film containing dexmedetomidine (BXCL501)
Experimental: 180 Micrograms Sublingual film containing 180 Micrograms dexmedetomidine	Drug: Sublingual film containing dexmedetomidine (BXCL501); Sublingual film containing dexmedetomidine (BXCL501)
Placebo Comparator: Placebo Sublingual placebo film	Drug: Placebo Film; Placebo Film for BXCL501

Outcome Measures

Primary Outcome Measures

1. Primary End Point [120 minutes]

   Absolute change from baseline in the PEC total score at 2 hours

Secondary Outcome Measures

1. key Secondary Endpoint [120 minutes]

   Earliest time where an effect on agitation is apparent as measured by change from baseline PEC total score in contrast with placebo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

A subject will be eligible for inclusion in the study if he or she meets the following criteria:

1. Male and female patients between the ages of 18 to 75 years, inclusive.

2. Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.

3. 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).

4. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.

5. Patients who read, understand, and provide written informed consent.

6. 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.

7. Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

A subject will be excluded from the study if he or she meets the following criteria:

1. 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.

2. Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.

3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.

4. Patients who are judged to be at significant risk of suicide

5. Female patients who have a positive pregnancy test at screening or are breastfeeding.

6. 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.

7. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.

8. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.

9. Patients with serious or unstable medical illnesses.

10. Patients who have received an investigational drug within 30 days prior to the current agitation episode.

11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BioXcel Clinical Research Site	Little Rock	Arkansas	United States	72211
2	BioXcel Clinical Research Site	Cerritos	California	United States	78754
3	BioXcel Clinical Research Site	Culver City	California	United States	90230
4	BioXcel Clinical Research Site	Long Beach	California	United States	90806
5	BioXcel Clinical Research Site	Orange	California	United States	92868
6	BioXcel Clinical Research Site	Miami Lakes	Florida	United States	33016
7	BioXcel Clinical Research Site	Chicago	Illinois	United States	60640
8	BioXcel Clinical Research Site	Gaithersburg	Maryland	United States	20877
9	BioXcel Clinical Research Site	Las Vegas	Nevada	United States	89102
10	BioXcel Clinical Research Site	Berlin	New Jersey	United States	08009
11	BioXcel Clinical Research Site	Marlton	New Jersey	United States	08053
12	BioXcel Clinical Research Site	Charleston	South Carolina	United States	29407
13	BioXcel Clinical Research Site	Austin	Texas	United States	78754
14	BioXcel Clinical Research Site	DeSoto	Texas	United States	75115
15	BioXcel Clinical Research Site	Richardson	Texas	United States	75080

Sponsors and Collaborators

• BioXcel Therapeutics Inc
• Cognitive Research Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioXcel Therapeutics Inc
• ClinicalTrials.gov Identifier: NCT04268303
• Other Study ID Numbers: BXCL501-301
• First Posted: Feb 13, 2020
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psychomotor Agitation; Disease; Schizophrenia; Psychotic Disorders; Mood Disorders; Dexmedetomidine

Study Results

No Results Posted as of Aug 19, 2020