SCHIZOPHRENIA AND BIPOLAR DISORDER MedDRA version: 19.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 19.0 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: ADASUVE
Product Name: Adasuve
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: loxapine
CAS Number: 1977-10-2
Other descriptive name: LOXAPINE
Concentration unit:
Sponsors
Ferrer Internacional, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients between the ages of 18 to 65 years, inclusive. 2. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-5 criteria for schizophrenia or bipolar disorder I. 3. Patients judged to be clinically agitated at baseline with a value of = 4 out of the 7 items on the CGI S scale. 4. Written informed consent from patients with documented adequate consent capacity per the Investigator’s judgement. 5. Patients in good general health prior to study participation as judged by the Investigator and stated in the patient’s record. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 468 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with agitation caused primarily by acute intoxication (as per Investigator’s judgment). 2. Patients with acute alcohol or psychoactive drugs intoxication/withdrawal symptoms incompatible with their participation in the study as judged by the Investigator. 3. Patients judged to be at serious risk for suicide as per the Investigator’s judgement. 4. Patients treated with benzodiazepines or other hypnotics or oral or short-acting IM antipsychotics within 1 hour prior to study drug administration (however, those patients may be subsequently reassessed for inclusion). 5.Patients with a history of allergy or intolerance to loxapine or amoxapine and/or aripiprazole. 6. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding or inpatients who previously had a positive serum pregnancy test upon admission. 7. Patients with previous laboratory or electrocardiogram abnormalities considered relevant by the Investigator that may have clinical implications for the patient's participation in the study. 8. Patients with significant hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic or hematologic disease. 9. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease). 10. Patients who received an investigational drug within 30 days prior to screening. 11. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, defined as time to response (where response is defined as a Clinical Global Impression of Improvement [CGI I] score of 1 [“Very much improved”] or 2 [“Much improved”]), of inhaled loxapine 9.1 mg as compared with aripiprazole 9.75 mg administered as an intramuscular (IM) injection in acutely agitated patients with schizophrenia or bipolar disorder.;Secondary Objective: • To evaluate efficacy, defined as percentage of responders at 10, 20, 30, 50, 60, 90 and 120 minutes of inhaled loxapine 9.1 mg as compared with aripiprazole 9.75 mg IM. • To assess the proportion of patients who needed an additional dose of study medication. • To assess the proportion of patients who needed rescue medication. • To assess patient satisfaction with inhaled loxapine compared with aripiprazole. • To evaluate and compare the safety and tolerability of study medication.;Primary end point(s): Efficacy Endpoint: • Time to response, where response is defined as a CGI I score of 1 (“Very much improved”) or 2 (“Much improved”). ;Timepoint(s) of evaluation of this end point: Post treatment Evaluation Period, which will start with the administration of Dose 1 of the study medication and will continue for at least 4 hours and for a maximum of 24 hours after Dose 1 or the end of the agitation episode as per the Investigator’s judgement, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory Endpoints: • The proportion of responders, as defined by a CGI I score of 1 or 2 at 10, 20, 30, 50, 60, 90 and 120 minutes after the first dose of study drug administration. • The value of the CGI-I score at 10, 20, 30, 50, 60, 90 and 120 minutes following Dose 1 of inhaled loxapine compared with aripiprazole. • Total number of patients per group who received 1 or 2 doses of study medication with and without rescue medication by 4 hours and 24 hours after Dose 1 or the end of the agitation episode as per the Investigator’s judgement, whichever occurs first. • Time to rescue medication during the entire Post-treatment Evaluation Period. • Time to Dose 2 (PRN) of study medication during the Post-treatment Evaluation Period as compared between groups. • Satisfaction with study treatment (based on Item 14 of the TSQM) as compared between groups.;Timepoint(s) of evaluation of this end point: Berween 10 minutes and 24 hours after the first dose of study drug administration. | — |
Countries
Czech Republic, Germany, Russian Federation, Spain
Contacts
Public ContactClinical Development
Ferrer Internacional, S.A.
Outcome results
None listed