The phase IIb clinical trial is an outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study in approximately 400 migraine patients with or without aura. Four doses will be evaluated in the clinical trial, placebo and 5mg, 7.5mg and 10mg doses of AZ-001.
Using the International Headache Society (IHS) 4-point rating scale, the primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations will also be made throughout the clinical trial period.
AZ-001 combines Alexza’s proprietary Staccato system with prochlorperazine, a drug belonging to the class of compounds known as phenothiazines. Prochlorperazine is currently approved in the United States for the treatment of several indications, including nausea and vomiting. In several published clinical studies, 10 mg of prochlorperazine administered intravenously demonstrated effective relief of migraine pain.
The company believes that AZ-001 could potentially result in a speed of therapeutic onset advantage over oral tablets, and a convenience and comfort advantage over injections.
“This clinical trial with AZ-001 in migraine patients is our first study with a Staccato product candidate in a non-clinical setting,” said Thomas King, Alexza president and CEO. “We believe the potential value of the non- invasive nature and rapid onset of pharmacological action provided by our Staccato system is well-suited for migraine pain relief in the outpatient setting.”