Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting

NCT02525991 | Completed Phase 4

• 1 other identifier: FER-Loxapine-2015-01
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.

Conditions

Agitation

Keywords

schizophrenia; bipolar disorder

Outcome Measures

Primary Outcomes (1)

• Serious adverse events and adverse events of special interest ( respiratory)

  To assess the safety profile of self-administered ADASUVE® outside the hospital setting in a population of patients that are known ADASUVE® responders and well trained on the use of the product, with a primary focus on serious adverse events (SAEs) and adverse events of special interest (AESI) related to ADASUVE®, including respiratory events

  one year

Secondary Outcomes (2)

• time to improvement of the agitation episode after the self-administration of ADASUVE® outside the hospital setting.

  one year

• Prevalence of the medication for treating agitation episode in the hospital setting after self-administration of ADASUVE®.

  one year

Study Arms (1)

Staccato® Delivery System Loxapine

EXPERIMENTAL

Staccato® Delivery System Loxapine, 9.1 mg one dose

Device: Staccato® Delivery System Loxapine (ADASUVE®)

Interventions

Staccato® Delivery System Loxapine (ADASUVE®) DEVICE

one dose Loxapine Staccato 9.1 mg

Also known as: ADASUVE®

Staccato® Delivery System Loxapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between the ages of 18-65 years, inclusive
• Patients (or legal representative) willing and able to provide written Informed Consent Form.
• Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria.
• Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting.
• Previously treated with ADASUVE® with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
• Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema).
• Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) ≤ 80 year old, who spend ≥ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).
• Availability of patient's medical records data about the previous treatment with ADASUVE® at hospital setting.
• If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.

You may not qualify if:

• Patient diagnosed with dementia.
• Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis).
• Patients with a history of allergic reactions to loxapine or amoxapine
• Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
• Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

Study Sites (1)

Ferrer Internacional S.A.

Barcelona, 08028, Spain

Location

Related Publications (1)

• Gil E, Garcia-Alonso F, Boldeanu A, Baleeiro Teixeira T; Loxapine Inhaled Home Use study investigator's team. Safety and efficacy of self-administered inhaled loxapine (ADASUVE) in agitated patients outside the hospital setting: protocol for a phase IV, single-arm, open-label trial. BMJ Open. 2018 Oct 2;8(10):e020242. doi: 10.1136/bmjopen-2017-020242.

  PMID: 30282677 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Thais B Teixeira, PharmD, PhD

  Ferrer Internacional SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention: treatment with Loxapine staccato- just one treatment arm - outside the hospital setting.

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 18, 2015
• Study Start: September 8, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

ES (1)