Condition or disease | Intervention/treatment | Phase |
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Agitation Schizophrenia | Drug: Sublingual film containing BXCL501 (Dexmedetomidine) Drug: Placebo film | Phase 1 |
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.
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 |
Arm | Intervention/treatment |
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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
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Drug: Placebo film
Placebo film for BXCL501
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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
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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
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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
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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.
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Drug: Sublingual film containing BXCL501 (Dexmedetomidine)
Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 3, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | January 31, 2020 | ||||
Actual Study Start Date ICMJE | May 22, 2019 | ||||
Actual Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | 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
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
135 | ||||
Original Estimated Enrollment ICMJE |
201 | ||||
Actual Study Completion Date ICMJE | July 31, 2019 | ||||
Actual Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04010305 | ||||
Other Study ID Numbers ICMJE | BXCL501-102 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | BioXcel Therapeutics Inc | ||||
Study Sponsor ICMJE | BioXcel Therapeutics Inc | ||||
Collaborators ICMJE | Cognitive Research Corporation | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | BioXcel Therapeutics Inc | ||||
Verification Date | January 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |