Staccato Prochlorperazine in Migraine (in Clinic)

Study Overview
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Brief Summary
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Development of Staccato Prochlorperazine for the treatment of migraine headache.

Official Title
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A Multi-center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache

Conditions
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Migraine Headache, With or Without Aura

Intervention / Treatment
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* Drug: Staccato Placebo
* Drug: Staccato Prochlorperazine 5 mg
* Drug: Staccato Prochlorperazine 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Inhaled Placebo<br>Inhaled Staccato Placebo | Drug: Staccato Placebo<br>* Inhaled Staccato Placebo<br>|
| Experimental: Inhaled PCZ 5 mg<br>Inhaled Staccato Prochlorperazine 5 mg | Drug: Staccato Prochlorperazine 5 mg<br>* Inhaled Prochlorperazine 5 mg<br>|
| Placebo Comparator: Inhaled PCZ 10 mg<br>Inhaled Staccato Prochlorperazine 10 mg | Drug: Staccato Prochlorperazine 10 mg<br>* Inhaled Prochlorperazine10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Pain Relief at 2 hr Post-dose by 2-point Definition | patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain | 2 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Analysis for Time to Pain Relief | Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition | from treatment (time = 0) to 2 hours post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.