BXCL501 for Acute Stress Disorder

(RISE Trial)

Not yet recruiting at 6 trial locations

Overseen By Romina Soudavari, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Opioids, Sedatives, Antihistamines, others

Disqualifiers: Pregnancy, Cardiac disease, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BXCL501, a potential medication to help manage stress and behavior changes after a car crash. The focus is on reducing acute stress reactions (the body's immediate response to trauma) and improving mental function and long-term stress symptoms. Participants will take the treatment shortly after visiting the emergency room and continue it for two weeks. Suitable candidates have visited the emergency room within 24 hours of a car accident and are expected to go home from there. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including those for alcoholism, some sedative antidepressants, and specific blood pressure medications. However, non-sedative antidepressants for PTSD are allowed.

Is there any evidence suggesting that BXCL501 is likely to be safe for humans?

Research has shown that BXCL501, also known as dexmedetomidine hydrochloride, is generally safe for people. One study found that BXCL501 was well-tolerated even when taken with alcohol. Another study suggested it could help treat conditions like PTSD and alcohol use disorder without major safety issues.

The safety of a 120 mcg dose of BXCL501, the same dose used in this trial, has been tested in other studies. These studies did not find any significant side effects, indicating that the treatment is well-tolerated. Since this trial is in an early phase, some safety data is available, but more research is needed to fully confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute stress disorder?

Unlike the standard treatments for Acute Stress Disorder, such as benzodiazepines and SSRIs, BXCL501 is a film containing dexmedetomidine HCl that dissolves under the tongue. This medication is unique because it targets the brain's alpha-2 adrenergic receptors, offering a calming effect without the sedation typically associated with other treatments. Researchers are excited about this treatment because it promises rapid relief from stress symptoms, potentially showing effectiveness in just days rather than weeks. Additionally, the sublingual delivery method is easy to use and avoids the need for injections or pills.

What evidence suggests that BXCL501 might be an effective treatment for Acute Stress Disorder?

This trial will compare BXCL501, a film that dissolves under the tongue, with a placebo. Studies have shown that BXCL501 can help reduce stress-related behaviors. Research indicates it may be effective for people who have experienced high stress, such as after a car accident. In previous studies, BXCL501 significantly reduced stress symptoms compared to a placebo. This suggests it could potentially help reduce immediate stress reactions and improve recovery after a traumatic event. ^{1 2 4 6 7}

Who Is on the Research Team?

Stacey House, MD

Principal Investigator

Washington University School of Medicine

Samuel McLean, MD

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a Motor Vehicle Collision and are at high risk of developing acute stress reactions or post-traumatic stress. Participants will receive treatment in the Emergency Department and must be able to take medication sublingually (under the tongue).

Inclusion Criteria

Consent to receive unencrypted communications

Has a smartphone with continuous service for ≥ 1 year

Able to speak and read English

Exclusion Criteria

Prisoner status

Hypomagnesia (<1.7 mg/dL) or hypokalemia (< 3.0 Milliequivalents (mEq/L))

Chronic daily opioid use prior to MVC (> 20 mg oral daily morphine equivalents)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive BXCL501 or placebo in the ED and continue treatment for 14 days with a sublingual film

2 weeks

Initial visit in ED, daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of psychological and somatic symptoms, neurocognitive function, and adverse events

12 weeks

Multiple assessments at Week 1, 3, 6, 12

What Are the Treatments Tested in This Trial?

Interventions

• BXCL501

Trial Overview The study tests BXCL501, a medication given under the tongue, against a placebo to see if it can reduce symptoms of acute stress reaction and prevent long-term post-traumatic stress after a car accident. It's a double-blind study with 100 participants.

How Is the Trial Designed?

Group I: BXCL501 (dexmedetomidine HCl) Experimental Treatment 1 Intervention

Participants will be instructed to take an initial dose of BXCL501 (equivalent to 1 film, 120mcg) in the ED as part of enrollment procedures. If the time between the first dose and the planned bedtime of the participant is greater than 6 hours, participants will be instructed to take the second dose at bedtime on the day of enrollment. If the time between the first dose and the planned bedtime of the participant is less than 6 hours participants will be instructed to take the second dose before bedtime on the day following enrollment. Following the initial dosing on the day of enrollment, all participants will be instructed to take a dose of study medication before bedtime until they have completed 14 days of treatment.

Group II: Placebo Placebo Group 1 Intervention

Participants will be instructed to take an initial dose of placebo (equivalent to 1 film, 120mcg) in the ED as part of enrollment procedures. If the time between the first dose and the planned bedtime of the participant is greater than 6 hours, participants will be instructed to take the second dose at bedtime on the day of enrollment. If the time between the first dose and the planned bedtime of the participant is less than 6 hours participants will be instructed to take the second dose before bedtime on the day following enrollment. Following the initial dosing on the day of enrollment, all participants will be instructed to take a dose of study medication before bedtime until they have completed 14 days of treatment.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Vanderbilt University School of Medicine

Collaborator

Trials

16

Recruited

13,900+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Walter Reed Army Institute of Research (WRAIR)

Collaborator

Trials

111

Recruited

108,000+

Published Research Related to This Trial

Cognitive-behavioral interventions have shown positive effects for treating Acute Stress Disorder (ASD), while psychodynamic therapy, cognitive-behavioral therapy, and EMDR are promising for Posttraumatic Stress Disorder (PTSD).

Selective Serotonin Reuptake Inhibitors (SSRIs) are the most studied and effective medications for both ASD and PTSD, offering a broader therapeutic effect and better tolerance compared to tricyclic antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic possibilities after traumatic experiences]. Kapfhammer, HP.[2008]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39152094/

Dexmedetomidine HCL (BXCL501) as a potential ... BXCL501 is safe for use in humans who may drink alcohol while undergoing treatment. BXCL501 may be explored as a potential treatment for PTSD and AUD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06943404

BXCL501 After Stress to Increase Recovery Success This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency ...

3. ir.bioxceltherapeutics.com ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-publication-frontiers

Press Release Dexmedetomidine demonstrated a significant reduction in stress-induced behaviors, suggesting potential applications of BXCL501 in chronic ...

4. withpower.com withpower.com/trial/phase-2-stress-disorders-traumatic-5-2025-f9707

BXCL501 for Acute Stress Disorder (RISE Trial) This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department ( ...

5. bioxceltherapeutics.gcs-web.com bioxceltherapeutics.gcs-web.com/news-releases/news-release-details/bioxcel-therapeutics-reports-positive-topline-exploratory

Press Release - BioXcel Therapeutics BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes ...

6. trialx.com trialx.com/clinical-trials/listings/325462/effect-of-sublingual-formulation-of-dexmedetomidine-hydrochloride-hcl-bxcl501-outpatient-study/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Effect of Sublingual Formulation of Dexmedetomidine ... The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/215390Orig1s000MultidisciplineR.pdf

215390Orig1s000 - accessdata.fda.gov Summary of Primary Efficacy Results for Studies BXCL501-301 and ... along with safety data from the dexmedetomidine oral film development program.