Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Condition: Agitation Associated With Bipolar Disorder; Agitation,Psychomotor; Bipolar Disorder
MeSH terms: Psychomotor Agitation; Bipolar Disorder
Intervention: Sublingual film containing Dexmedetomidine (BXCL501); Placebo Film
Intervention description: Sublingual film containing Dexmedetomidine (BXCL501); Placebo Film for BXCL501
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: phase III, randomized, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, placebo-controlled
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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:

          1. Male and female patients between the ages of 18 to 75 years, inclusive.

          2. Patients who have met DSM-5 criteria for bipolar I or II disorder.

          3. 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).

          4. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.

          5. Patients who read, understand and provide written informed consent.

          6. 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.

          7. Participants who agree to use a medically acceptable and effective birth control
             method

        Exclusion Criteria:

          1. 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.

          2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular
             antipsychotic drugs in the 4 hours before study treatment.

          3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin,
             alfuzosin, or prazosin) or other prohibited medications.

          4. Patients who are judged to be at significant risk of suicide.

          5. Female patients who have a positive pregnancy test at screening or are breastfeeding.

          6. 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.

          7. History of syncope or other syncopal attacks, current evidence of hypovolemia,
             orthostatic hypotension.

          8. Patients with laboratory or ECG abnormalities considered clinically significant by the
             investigator.

          9. Patients with serious or unstable medical illnesses.

         10. Patients who have received an investigational drug within 30 days prior to the current
             agitation episode.

         11. Patients who are considered by the investigator, for any reason, to be an unsuitable
             candidate for receiving DEX.