NCT04010305|CompletedPhase 1FDA Drug

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

A Phase Ib Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine Efficacy, Pharmacokinetics and Safety of BXCL501 in Agitation Associated With Schizophrenia

BioXcel Therapeutics Inc ClinicalTrials.gov

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1 other identifier

BXCL501-102

Study Type

interventional

Target

135

Locations

1 country

Sites

Timeline

RegisteredJul 2019

StartedMay 2019

CompletionJul 2019

Brief Summary

This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the second stage.

Trial Health

On Track

Trial Health Score

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

Enrollment

135

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started May 2019

Shorter than P25 for phase_1

Geographic Reach

1 country

12 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 months study duration

Study Start

First participant enrolled

May 22, 2019

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed

23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

July 3, 2019

Last Update Submit

February 6, 2023

Conditions

Agitation Schizophrenia

Outcome Measures

Primary Outcomes (1)

PANSS-EC Change From Baseline
Positive and Negative Syndrome Scale - Excited Component (PEC). The PEC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 to 35.
120 minutes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Sublingual Film with no active drug; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Drug: Placebo film

20 micrograms

EXPERIMENTAL

Sublingual Film containing 20 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Drug: Sublingual film containing BXCL501 (Dexmedetomidine)

60 micrograms

EXPERIMENTAL

Sublingual Film containing 60 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Drug: Sublingual film containing BXCL501 (Dexmedetomidine)

120 micrograms

EXPERIMENTAL

2 Sublingual Films, each containing 60 micrograms BXCL501; single administration of 2 films with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Drug: Sublingual film containing BXCL501 (Dexmedetomidine)

180 micrograms

EXPERIMENTAL

2 Sublingual Films, each containing 60 micrograms BXCL501.

Drug: Sublingual film containing BXCL501 (Dexmedetomidine)

Interventions

Sublingual film containing BXCL501 (Dexmedetomidine)DRUG

Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia

Also known as: Dexmedetomidine

120 micrograms180 micrograms20 micrograms60 micrograms

Placebo filmDRUG

Placebo film for BXCL501

Also known as: Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 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 65 years, inclusive.
Patients who have met Diagnostic and Statistical Manual (DSM) -5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
Patients who are judged to be clinically agitated at 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.
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, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
Female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.

You may not qualify if:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or non-prescription drugs (with the exception of THC) during urine screening.
Patients treated within 4 hours prior to study drug administration with benzodiazepines, other hypnotics or oral or short-acting intramuscular antipsychotics.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, and alfuzosin, and prazosin) or other prohibited medications.
Patients with significant risk of suicide or homicide per the investigator's assessment, or any suicidal behavior in last 6 months prior to screening.
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, a screening heart rate of \< 55 beats per minutes or systolic blood pressure \<110 mmHg or diastolic BP \<70 mmHg.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator or qualified designee \[Advanced heart block (second-degree or above atrioventricular block without pacemaker), diagnosis of Sick sinus syndrome\] that would have clinical implications for the patient's participation in the study.
Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are unable to use the sublingual film or considered by the investigator, for any reason, to be an unsuitable candidate for receiving dexmedetomidine; e.g. patients with a history of allergic reactions to dexmedetomidine.

Contact the study team to confirm eligibility.