Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 5 for:    bxcl501 | Phase 1, 2

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251910
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Cognitive Research Corporation
Information provided by (Responsible Party):
BioXcel Therapeutics Inc

Brief Summary:
This is an adaptive Phase 1b trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia.

Condition or disease Intervention/treatment Phase
Agitation,Psychomotor Dementia Drug: Sublingual film containing Dexmedetomidine Drug: Sublingual Placebo Film Phase 1 Phase 2

Detailed Description:
This is a Phase 1b randomized, double-blind, placebo controlled, ascending dose finding study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL501 with 3 dosing groups in adult (65 years and older) males and females with acute agitation associated with all forms of dementia. Evaluation of three (3) doses of sublingual BXCL 501 are planned. Cohort 1, Cohort 2 and Cohort 3 will be given 30µg, 60µg and 90µg dose respectively of BXCL501 or placebo. This is an adaptive design as doses selected for testing may be different from these, based upon safety reviews. Doses lower or higher may be chosen to test, up to 180µg. BXCL501 films may be divided in half if needed to deliver half-dose strengths. At least 30 subjects (10 per cohort) will be enrolled at up to 3 study sites in the United States. The effects of BXCL 501 on acute agitation will be assessed by the following scales: Pittsburgh Agitation Scale (PAS), the PANSS-EC (PEC), Cohen-Mansfield Agitation Inventory (CMAI), CGI-Severity for Agitation and CGI Improvement for Agitation. Adverse Events (AEs), clinical laboratory tests, ECG, and vital signs will be monitored, and all observed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) 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/II, Multicenter, Randomized, Double Blind, Placebo Controlled, Ascending Dose Finding, Efficacy, Pharmacokinetic and Safety Study of BXCL501 In Agitation Associated With Dementia
Actual Study Start Date : December 27, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Active Comparator: Cohort 1- 30 Micrograms
Cohort 1 consists of 10 patients out of whom 8 patients receive 30 Micrograms film and the remaining 2 patients receive a placebo
Drug: Sublingual film containing Dexmedetomidine
Sublingual film containing Dexmedetomidine
Other Name: BXCL501

Drug: Sublingual Placebo Film
Sublingual placebo film that matches BXCL501

Active Comparator: Cohort 2- 60 Micrograms
Cohort 2 consists of 10 patients out of whom 8 patients receive 60 Micrograms film and the remaining 2 patients receive a placebo
Drug: Sublingual film containing Dexmedetomidine
Sublingual film containing Dexmedetomidine
Other Name: BXCL501

Drug: Sublingual Placebo Film
Sublingual placebo film that matches BXCL501

Active Comparator: Cohort 3- 90 Micrograms
Cohort 3 consists of 10 patients out of whom 8 patients receive 90 Micrograms film and the remaining 2 patients receive a placebo
Drug: Sublingual film containing Dexmedetomidine
Sublingual film containing Dexmedetomidine
Other Name: BXCL501

Drug: Sublingual Placebo Film
Sublingual placebo film that matches BXCL501




Primary Outcome Measures :
  1. Incidence of AEs [ Time Frame: 7 days ]
    Incidence of AEs

  2. Incidence of abnormal laboratory test results [ Time Frame: 7 days ]
    Incidence of abnormal laboratory test results

  3. Incidence of abnormal vital signs [ Time Frame: 7 days ]
    Incidence of abnormal vital sign (systolic and diastolic blood pressures, heart rate measured as pulse, respiratory rate, and temperature)

  4. Incidence of abnormal ECG findings [ Time Frame: 7 days ]
    Incidence of abnormal ECG findings


Secondary Outcome Measures :
  1. Magnitude of calming effects [ Time Frame: 24 hours ]
    Magnitude of calming effects of different doses of BXCL501 on symptoms of acute agitation associated with dementia as measured by the Pittsburgh Agitation Scale (PAS) (Minimum Score value: 0. Maximum score value 16. higher scores mean a worse outcome).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 criterion for agitation.
  • Patients with a total score of ≥ 8 on the Pittsburgh Agitation Scale (PAS).
  • Patients who have a score of ≥ 2 on at least 1 of the 4 items on the Pittsburgh Agitation Scale (PAS).
  • Patients who read, understand and provide written informed consent, or who have a Legally Authorized Representative (LAR).
  • Patients who are in good general health.

Exclusion Criteria:

  • Patients with agitation caused by acute intoxication.
  • Patients treated within 4 hours prior to study drug administration with benzodiazepines, other sedatives, hypnotics or oral or short-acting intramuscular antipsychotics must be excluded.
  • Treatment with alpha-1 noradrenergic blockers, alpha adrenergic antagonists within 8 hours prior to dosing.
  • No new chronic medications initiated in the past 14 days prior to screening excluding over-the-counter products taken sporadically.
  • Patients at significant risk of harm to themselves or others
  • Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
  • Patients experiencing clinically significant pain, per Investigator.

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): NCT04251910


Contacts
Layout table for location contacts
Contact: Andressa de Oliveira 475-238-6837 adoliveira@bioxceltherapeutics.com
Contact: Cedric Burg 475-238-6837 cburg@bioxceltherapeutics.com

Locations
Layout table for location information
United States, Florida
BioXcel Clinical Research Site Recruiting
Miami Lakes, Florida, United States, 33016
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
Sponsors and Collaborators
BioXcel Therapeutics Inc
Cognitive Research Corporation
Layout table for additonal information
Responsible Party: BioXcel Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04251910    
Other Study ID Numbers: BXCL501-103
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
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