Alpha-2A Adrenergic Receptor Agonist

80 Micrograms for Schizophrenia

Phase 1
Recruiting
Research Sponsored by BioXcel Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC)
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up90, 60, 45, 30, 20,10 minutes - group one only
Awards & highlights

Study Summary

This trial shows that BXCL501 is safe and effective in treating children and adolescents with bipolar disorder or schizophrenia who are experiencing acute agitation.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
Patients who are judged to be clinically agitated and have a total score of ≥14 on the 5 items that make up the PANSS Excited Component.
Select...
You are feeling very agitated or restless, and your score on a test called PANSS Excited Component is 14 or higher.
Select...
You have a high score on a questionnaire called the PEC, which measures certain symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90, 60, 45, 30, 20,10 minutes - group one only
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90, 60, 45, 30, 20,10 minutes - group one only for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Syndrome

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 MicrogramsExperimental Treatment1 Intervention
Sublingual film containing 80 micrograms Dexmedetomidine
Group II: 60 MicrogramsExperimental Treatment1 Intervention
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Group III: 120 MicrogramsExperimental Treatment1 Intervention
Sublingual film containing 120 micrograms Dexmedetomidine
Group IV: PlaceboPlacebo Group1 Intervention
Sublingual Placebo film

Find a site

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
17 Previous Clinical Trials
2,287 Total Patients Enrolled
4 Trials studying Schizophrenia
985 Patients Enrolled for Schizophrenia
Cognitive Research CorporationIndustry Sponsor
21 Previous Clinical Trials
2,163 Total Patients Enrolled
3 Trials studying Schizophrenia
841 Patients Enrolled for Schizophrenia
Robert Risinger, MDStudy Chair
BioXcel Therapeutics
9 Previous Clinical Trials
1,594 Total Patients Enrolled
5 Trials studying Schizophrenia
1,188 Patients Enrolled for Schizophrenia

Media Library

BXCL501 (Alpha-2A Adrenergic Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05025605 — Phase 1
Schizophrenia Research Study Groups: 80 Micrograms, 120 Micrograms, Placebo, 60 Micrograms
Schizophrenia Clinical Trial 2023: BXCL501 Highlights & Side Effects. Trial Name: NCT05025605 — Phase 1
BXCL501 (Alpha-2A Adrenergic Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025605 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other trials been conducted to assess the efficacy of BXCL501?

"Currently, there are 110 clinical trials evaluating the efficacy of BXCL501 with 23 studies in their last phase. Most of these tests take place in Karachi, Sindh though there exist 207 sites across the world running this medication's research."

Answered by AI

Who is eligible to take part in this medical experiment?

"This schizophrenia study requires 140 minors between the ages of 10 and 17. Inclusion criteria include a total score of at least 14 on the PANSS Excited Component (PEC) during screening and baseline, an agreement to use reliable birth control methods, as well as a score greater than 4 on one or more PEC items at Baseline."

Answered by AI

How many medical institutions are engaged in executing this experiment?

"At the moment, this clinical trial is being conducted at 6 different sites. These can be found in Orem, Atlanta and Hialeah as well as 3 other cities. To reduce travel requirements for participants it would make sense to pick a clinic that's closest to your location if you enroll."

Answered by AI

Are there still openings available for volunteers to participate in this research endeavor?

"Indeed, according to clinicaltrials.gov, this research initiative is actively enrolling participants; its initial posting was on August 27th 2021 and the most recent update was September 26th 2022. The study seeks 140 volunteers at 6 separate facilities."

Answered by AI

What medical issues is BXCL501 typically administered for?

"BXCL501 is a therapeutic agent used to manage the unsettling symptoms of diseases like ventilations, mechanical, and cyclic vomiting syndrome."

Answered by AI

Has BXCL501 been given the go-ahead by the Food and Drug Administration?

"Due to the limited amount of evidence available for its safety and efficacy, BXCL501 received a score of 1."

Answered by AI

What is the upper bound of participants in this research endeavor?

"Affirmative. This trial is looking for volunteers, and the information found on clinicaltrials.gov confirms this fact. It was first posted in August of 2021 and its most recent update was from September 2022. The experiment needs 140 patients to be recruited from 6 different research centres."

Answered by AI

Does the eligibility criteria for this experiment extend to persons aged 40 and above?

"This trial is targeting individuals aged 10 to 17. On clinicaltrials.gov, there are 367 studies open for minors and 911 trials available to senior citizens above 65 years of age."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
BioXcel Clinical Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~40 spots leftby Jul 2024