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Alpha-2A Adrenergic Receptor Agonist
BXCL501 for Pediatric Schizophrenia and Bipolar Agitation
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
Male and female subjects between the ages of 10-17 years with bipolar disorder (DSM-5 criteria)
Male and female subjects between the ages of 13-17 years with schizophrenia (DSM-5 criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90, 60, 45, 30, 20,10 minutes - group one only
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.
Who is the study for?
This trial is for children and teens aged 10-17 with bipolar disorder, and those aged 13-17 with schizophrenia who are experiencing significant agitation. They must have a specific level of agitation on the PANSS Excited Component scale and agree to use effective birth control. It's not for those who've used certain sedatives recently, are at suicide risk, have serious health issues, or have taken experimental drugs within the last month.
What is being tested?
The study tests BXCL501 at different doses (60, 80, and 120 micrograms) against a placebo to see if it helps calm down kids and teens with bipolar disorder or schizophrenia during acute agitation episodes. The effectiveness and safety of these treatments are being compared.
What are the potential side effects?
While the side effects aren't specified here, common ones for psychiatric medications like BXCL501 could include drowsiness, headache, stomach upset, changes in appetite or weight; mood swings; dry mouth; increased saliva production; or restlessness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10-17 years old and have been diagnosed with bipolar disorder.
Select...
I am a teenager aged 13-17 with schizophrenia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90, 60, 45, 30, 20,10 minutes - group one only
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90, 60, 45, 30, 20,10 minutes - group one only
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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
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Who is running the clinical trial?
BioXcel Therapeutics IncLead Sponsor
19 Previous Clinical Trials
2,215 Total Patients Enrolled
5 Trials studying Schizophrenia
1,020 Patients Enrolled for Schizophrenia
Cognitive Research CorporationIndustry Sponsor
24 Previous Clinical Trials
2,248 Total Patients Enrolled
4 Trials studying Schizophrenia
881 Patients Enrolled for Schizophrenia
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,685 Total Patients Enrolled
5 Trials studying Schizophrenia
1,191 Patients Enrolled for Schizophrenia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.Patients who have a score of ≥ 4 on any of the 5 items on the PEC at Baseline.I haven't taken any sleep or antipsychotic medication in the last 4 hours.I am between 10-17 years old and have been diagnosed with bipolar disorder.I am a teenager aged 13-17 with schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: 80 Micrograms
- Group 2: 120 Micrograms
- Group 3: Placebo
- Group 4: 60 Micrograms
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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