Phase 3
N=380
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Agitation Associated With Bipolar Disorder · Agitation,Psychomotor · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04276883 ↗Enrolled (actual)
380
Serious AEs
0.3%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score — 18.0; 18.0; 17.9; -10.4 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sublingual film containing Dexmedetomidine (BXCL501) (Drug); Placebo Film (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioXcel Therapeutics Inc
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score |
18.0; 18.0; 17.9; -10.4; -9.0; -4.9 | <0.0001 sig |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time |
18; 18; 17.9; -3.1; -2.9; -1.9 | <0.0001 sig |
Summary
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.
Eligibility Criteria
Inclusion Criteria
- Male and female patients between the ages of 18 to 75 years, inclusive.
- Patients who have met DSM-5 criteria for bipolar I or II disorder.
- Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
- Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
- Patients who read, understand and provide written informed consent.
- Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
- Participants who agree to use a medically acceptable and effective birth control method
Exclusion Criteria
- Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
- Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
- Patients who are judged to be at significant risk of suicide.
- Female patients who have a positive pregnancy test at screening or are breastfeeding.
- Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
- History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
- Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
- Patients with serious or unstable medical illnesses.
- Patients who have received an investigational drug within 30 days prior to the current agitation episode.
- Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.
Data sourced from ClinicalTrials.gov (NCT04276883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.