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Staccato Loxapine in Migraine (Out Patient)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00825500
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 19, 2009
First Posted Date  ICMJE January 21, 2009
Results First Submitted Date  ICMJE March 13, 2017
Results First Posted Date  ICMJE April 24, 2017
Last Update Posted Date April 24, 2017
Study Start Date  ICMJE January 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
Pain-Relief at 2 Hours Post-treatment [ Time Frame: 2 hours ]
Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
Pain-Relief [ Time Frame: 2 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
Photophobia Free [ Time Frame: 2 hours ]
Free of Photophobia at 2 Hours Post-treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
Pain free, Nausea, Photophobia, Phonophobia [ Time Frame: 2 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Staccato Loxapine in Migraine (Out Patient)
Official Title  ICMJE A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache
Brief Summary Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.
Detailed Description This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: Inhaled Placebo
    Inhaled Staccato placebo (0 mg)
  • Drug: Inhaled Loxapine 1.25 mg
    Inhaled Staccato Loxapine 1.25 mg, single dose
  • Drug: Inhaled Loxapine 2.5 mg
    Inhaled Staccato Loxapine 1.25 mg, single dose
Study Arms  ICMJE
  • Placebo Comparator: Inhaled Placebo
    Inhaled Staccato Placebo (0 mg)
    Intervention: Drug: Inhaled Placebo
  • Active Comparator: Inhaled Loxapine 1.25 mg
    Inhaled Staccato Loxapine 1.25 mg, single dose
    Intervention: Drug: Inhaled Loxapine 1.25 mg
  • Experimental: Inhaled Loxapine 2.5 mg
    Inhaled Staccato Loxapine 2.5 mg, single dose
    Intervention: Drug: Inhaled Loxapine 2.5 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2009)
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2009)
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Male or female between the ages of 18 to 65 years, inclusive
  • History of migraine headache with or without aura (according to IHS Criteria 1.1 or 1.2 for diagnosis beginning at least 6 months prior to study entry) (International Headache Society Clinical Trials Subcommittee, 2000)
  • At least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks in the last month)
  • Pain rating of moderate or severe (on a none-mild- moderate-severe scale) prior to dosing
  • Agreed not to use the study drug within 72 hours of a prior migraine attack
  • Agreed not to use any acute migraine or pain medication within 48 hours prior to dosing (including over-the-counter [OTC] products); medications for migraine prophylaxis other than those that were exclusionary were permitted if stable doses had been given for at least 30 days prior to screening
  • Agreed not to use medications (including OTC products) for motion sickness, tinnitus, or vertigo within 48 hours prior to dosing.
  • Were able to speak, read, and understand English and were willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures
  • Were willing and able to comply with the study schedule and requirements, and agreed to return to the clinic within 5 working days of use of the study drug
  • In good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead electrocardiogram (ECG), blood chemistry profile, hematology, urinalysis, and in the opinion of the investigator
  • Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agreed to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception that could be used by the participant and/or his/her partner included 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 included the rhythm method, withdrawal, condoms alone, or diaphragm alone.

Exclusion Criteria

  • Use of antipsychotics (including butryophenones, phenothiazines, thioxanthenes, aripiprazle, olanzapine, risperidone), tricyclic antidepressants, trazodone, anticonvulsants (except topiramate), barbiturates, benzodiazepines, or lithium within 14 days or 5 half-lives, whichever was longer, of randomization and at anytime throughout the study
  • History of contraindications to anticholinergic agents (eg, bowel or urinary obstruction, stenosing peptic ulcers, narrow-angle glaucoma)
  • History of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine)
  • History of extrapyramidal disorders, movement disorders including Parkinson's disease or neuroleptic malignant syndrome
  • Female patients with a positive pregnancy test at screening or during randomization visit, or who were breastfeeding
  • History within the past year of drug or alcohol dependence or abuse as defined by DSM IV
  • History of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, or uncontrolled hypertension
  • History of a major neurological disorder other than migraine (seizure disorder, subarachnoid bleeding, stroke, brain tumor, or transient ischemic attack)
  • Any other disease(s), by history, physical examination, or laboratory abnormalities (including alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 2-fold the upper limit of normal, total bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL), that in the investigator's opinion, would present undue risk to the patient or could confound the interpretation of study results
  • History of asthma or chronic obstructive lung disease or any use of an inhaler prescribed for wheezing or bronchospasm in the past 5 years
  • Receipt of an investigational drug within 30 days prior to the screening visit
  • Considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00825500
Other Study ID Numbers  ICMJE AMDC-104-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Alexza Pharmaceuticals, Inc.
Original Responsible Party Robert S. Fishman, MD, Alexza Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Alexza Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roger K. Cady, MD Clinvest
Principal Investigator: Peter J. Bellafiore, MD CNS Research, Inc.
Principal Investigator: Arthur Elkind, MD Elkind Headache Center
PRS Account Alexza Pharmaceuticals, Inc.
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP