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Staccato Loxapine in Agitated Patients With Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00721955
First received: July 23, 2008
Last updated: May 30, 2017
Last verified: October 2008
  Purpose
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

Condition Intervention Phase
Bipolar I Disorder Drug: Inhaled Placebo Drug: Inhaled loxapine 5 mg Drug: Inhaled loxapine 10 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo [ Time Frame: 2 hr ]
    The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.


Secondary Outcome Measures:
  • Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo [ Time Frame: 2 hr ]
    Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.

  • CGI-I Responders [ Time Frame: 24 hr ]
    Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)


Enrollment: 314
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inhaled Placebo
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Drug: Inhaled Placebo
Inhaled loxapine Placebo, may repeat after 2 hours x 2
Other Name: Staccato Placebo
Experimental: Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Drug: Inhaled loxapine 5 mg
Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
Other Name: ADASUVE 5 mg
Experimental: Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Drug: Inhaled loxapine 10 mg
Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
Other Name: ADASUVE 10 mg

Detailed Description:
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

  • Agitation caused primarily by acute intoxication
  • History of drug or alcohol dependence
  • Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721955

Locations
United States, California
Synergy Escondido
Escondido, California, United States, 92025
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
Claghorn-Lesem Research Clinic
Houston, Texas, United States, 77008
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Study Director: Robert S Fishman, MD Alexza Pharmaceuticals, Inc.
  More Information

Publications:
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00721955     History of Changes
Other Study ID Numbers: AMDC-004-302
Study First Received: July 23, 2008
Results First Received: March 13, 2017
Last Updated: May 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexza Pharmaceuticals, Inc.:
Bipolar 1 disorder,
agitation,
acute,
treatment

Additional relevant MeSH terms:
Disease
Pathologic Processes
Loxapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2017