Development of Staccato Prochlorperazine for the treatment of migraine headache.

Inclusion Criteria:

• Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.

Exclusion Criteria:

• Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Safety Population

From informed consent through 30 days after last treatment

Adverse events (AE) observed by the Investigator or study personnel during study assessments and throughout post-dosing period or when volunteered by the patient regardless of treatment group or suspected causal relationship to study drugs were recorded on the AE CRF. The severity of the AE and relationship to study drug was determined by the investigator.