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Staccato Loxapine in Agitation (Proof of Concept)

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ClinicalTrials.gov Identifier: NCT00369577
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Inhaled Placebo Drug: Inhaled Loxapine 5 mg Drug: Inhaled Loxapine 10 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Single Dose Efficacy and Safety Study of StaccatoTM Loxapine for Inhalation in Schizophrenic Patients With Agitation.
Study Start Date : August 2006
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Inhaled Placebo
Inhaled Staccato Placebo, single dose
Drug: Inhaled Placebo
Inhaled Placebo, single dose
Other Name: Staccato Loxapine Placebo
Experimental: Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, single dose
Drug: Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, single dose
Other Names:
  • Inhaled Staccato Loxapine 5 mg
  • ADASUVE 5 mg
Experimental: Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, single dose
Drug: Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, single dose
Other Names:
  • Inhaled Staccato Loxapine 10 mg
  • ADASUVE 10 mg

Primary Outcome Measures :
  1. PANSS-EC Change From Baseline [ Time Frame: 2 hours ]
    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 :
  1. BARS Change From Baseline After Drug Treatment [ Time Frame: 2 hours ]
    Change from baseline on the Behavioral Activity Rating Scale (BARS) ranging from 1 to 7 where: 1 = difficult or unable to rouse, 2 = asleep but responds normally to verbal or physical contact, 3 = drowsy, appears sedated, 4 = quiet, and awake (normal level of activity), 5 = signs of overt (physical or verbal) activity, calms down with instructions, 6 = extremely or continuously active, not requiring restraint, 7 = violent, requires restraint.

  2. Clinical Global Impressions-Improvement Scale (CGI-I) After Drug Administration [ Time Frame: 2 hours ]
    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.

  3. CGI-I Responders [ Time Frame: 2 hours ]
    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)

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male and female patients between the ages of 18 to 65 years, inclusive.
  2. Patients who have met DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder.
  3. Patients who are judged to be clinically agitated at 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 value of ≥ 4 (out of 7) on at least 1 of the 5 items on the PANSS Excited Component.
  5. Patients who read and understand English 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, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
  7. Female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.

Exclusion Criteria:

  1. Patients with agitation caused by acute intoxication must be excluded. Positive identification of non-prescription drugs during urine screening excludes the subject.
  2. Patients treated with benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotics within 4 hours prior to study drug administration must be excluded.
  3. Patients treated with injectable depot neuroleptics within one dose interval prior to study drug administration must be excluded.
  4. Patients with a history of allergic reactions to loxapine or amoxapine must be excluded.
  5. Female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
  6. Patients who have Parkinson's disease, hydrocephalus, seizure disorder, or history of significant head trauma must be excluded.
  7. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator or qualified designee that would have clinical implications for the patient's participation in the study must be excluded.
  8. 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), or hematologic disease must be excluded.
  9. Patients who have a history of acute or chronic pulmonary disease that precludes administration of Staccato Loxapine (asthma, bronchitis, emphysema) must be excluded.
  10. Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
  11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369577

United States, California
Pacific Clinical Research Medical Group, 1317 West Foothill Blvd, Suite 200,
Upland, California, United States, 91786
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Principal Investigator: Daniel Zimbroff, MD Pacific Clinical Research Medical Group

Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00369577     History of Changes
Other Study ID Numbers: AMDC-004-201
First Posted: August 29, 2006    Key Record Dates
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018
Last Verified: June 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.:

Additional relevant MeSH terms:
Psychomotor Agitation
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
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