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Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010305
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Cognitive Research Corporation
Information provided by (Responsible Party):
BioXcel Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Agitation Schizophrenia Drug: Sublingual film containing BXCL501 (Dexmedetomidine) Drug: Placebo film Phase 1

Detailed Description:

This is a two-stage adaptive Phase Ib trial design. It is a randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL501 dosing in adult (18-65 years old) males and females with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

The first stage will characterize a safe and tolerable dose range that results in a calming effect as measured using the PEC total score. The lowest dose with clear clinical benefit, and the highest safe and well-tolerated dose that demonstrates efficacy in a large proportion of subjects will be selected over the course of testing multiple escalating dose cohorts. The second stage will comprise a total of 40 subjects per dose group in a three-arm placebo-controlled design in order to better characterize the broader range of safety and tolerability as well as better estimate variability (effect size) which may be observed in later phase placebo-controlled trials.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-stage adaptive Phase Ib trial design. It is a randomized, double-blind, placebo-controlled, multiple ascending dose study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind study. Due to the nature of the drug, the pharmacist and the drug administrator will both be aware of the treatment. They have no other responsibility in the trial
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 22, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo
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
Placebo film for BXCL501

Experimental: 20 micrograms
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)
Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia

Experimental: 60 micrograms
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)
Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia

Experimental: 120 micrograms
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)
Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia

Experimental: 180 micrograms
2 Sublingual Films, each containing 60 micrograms BXCL501.
Drug: Sublingual film containing BXCL501 (Dexmedetomidine)
Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia




Primary Outcome Measures :
  1. PANSS-EC Change From Baseline [ Time Frame: 120 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients between the ages of 18 to 65 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 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.
  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, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Patients treated within 4 hours prior to study drug administration with benzodiazepines, other hypnotics or oral or short-acting intramuscular antipsychotics.
  3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, and alfuzosin, and prazocin) or other prohibited medications.
  4. Patients with significant risk of suicide or homicide per the investigator's assessment, or any suicidal behavior in last 6 months prior to screening.
  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, a screening heart rate of < 55 beats per minutes or systolic blood pressure <110 mmHg or diastolic BP <70 mmHg.
  8. 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.
  9. 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.
  10. Patients who have received an investigational drug within 30 days prior to the current agitation episode.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010305


Locations
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United States, Arkansas
BioXcel Clinical Research Site
Little Rock, Arkansas, United States, 72211
United States, California
BioXcel Clinical Research Site
Cerritos, California, United States, 90703
BioXcel Clinical Research Site
Lemon Grove, California, United States, 91945
BioXcel Clinical Research Site
Long Beach, California, United States, 90806
BioXcel Clinical Research Site
Orange, California, United States, 92868
United States, Florida
BioXcel Clinical Research Site
Miami Lakes, Florida, United States, 33016
United States, Georgia
BioXcel Clinical Research Site
Atlanta, Georgia, United States, 30331
United States, Maryland
BioXcel Clinical Research Site
Gaithersburg, Maryland, United States, 20877
United States, Mississippi
BioXcel Clinical Research Site
Flowood, Mississippi, United States, 39232
United States, New Jersey
BioXcel Clinical Research Site
Berlin, New Jersey, United States, 08009
United States, Texas
BioXcel Clinical Research Site
Austin, Texas, United States, 78754
BioXcel Clinical Research Site
Richardson, Texas, United States, 75080
Sponsors and Collaborators
BioXcel Therapeutics Inc
Cognitive Research Corporation

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Responsible Party: BioXcel Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04010305    
Other Study ID Numbers: BXCL501-102
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychomotor Agitation
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action