Staccato Loxapine in Migraine (in Clinic)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Staccato Loxapine; Staccato Placebo
Intervention description: Placebo aerosol inhalation (0mg)
Intervention MeSH terms: Loxapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staccato® Loxapine, Migraine

Summary:

      The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in
      patients with migraine headache with or without aura in a clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients between the ages of 18 to 65 years, inclusive.

          2. Patients who have migraine headache with or without aura (diagnosis according to
             International Headache Society guidelines) for at least 6 months.

          3. Patients who have a history of migraine and have had at least 3 migraine attacks in
             the last 3 month period (but not more than 8 migraine attacks in the last month).

          4. Patients who have been pain free for at least 48 hours since the end of their last
             migraine attack.

          5. Patients who have not taken any acute migraine or pain medication within 48 hours
             prior to dosing (including OTC products).

          6. Patients who have a pain rating of Moderate or Severe (on a None-Mild- Moderate-Severe
             Scale) prior to dosing.

          7. Patients who speak, read, and understand English and are willing and able to provide
             written informed consent on an IRB approved form prior to the initiation of any study
             procedures.

          8. Patients who are willing and able to comply with the study schedule and requirements,
             are willing and able to travel to the Clinical Research Unit (CRU) for treatment and
             stay at the CRU for approximately a 4-6 hour period, and agree to return to the clinic
             within 5 working days of use of the investigational treatment.

          9. 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.

         10. 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 who are currently taking antipsychotics, tricyclic antidepressants,
             valproate, barbiturates, benzodiazepines, or lithium must be excluded.

          2. Patients with a history of contraindications to anticholinergics (bowel obstruction,
             urinary retention, acute glaucoma) must be excluded.

          3. Patients with a history of allergy or intolerance to dibenzoxazepines (loxapine and
             amoxapine) must be excluded.

          4. Patients with a history of extra-pyramidal disorders, movement disorders including
             Parkinson's disease, and patients with a history of neuroleptic malignant syndrome
             must be excluded.

          5. Female patients who have a positive pregnancy test at screening or during
             randomization visit, or are breastfeeding must be excluded.

          6. Patients who have a history within the past year of drug or alcohol dependence or
             abuse as defined by DSM-4 must be excluded.

          7. Patients who have a history of syncope, unstable angina, myocardial infarction (within
             6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma
             must be excluded.

          8. Patients who have a history of a major neurological disorder other than migraine
             (seizure disorder, subarachnoid bleeding, stroke, brain tumor) must be excluded.

          9. Patients who have any other disease(s), by history, physical examination, or
             laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, Bilirubin >
             1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion, would
             present undue risk to the patient or may confound the interpretation of study results
             must be excluded.

         10. Patients who have a history of asthma or chronic obstructive lung disease should be
             excluded.

         11. Patients who have received an investigational drug within 30 days prior to the
             Screening Visit must be excluded.

         12. 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.