Staccato Loxapine in Migraine (Out Patient)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Inhaled Placebo; Inhaled Loxapine 1.25 mg; Inhaled Loxapine 2.5 mg
Intervention description: Inhaled Staccato placebo (0 mg); Inhaled Staccato Loxapine 1.25 mg, single dose; Inhaled Staccato Loxapine 1.25 mg, single dose
Intervention MeSH terms: Loxapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine headache; Loxapine; Staccato

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.
    

Eligibility criteria:

        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