Staccato Prochlorperazine in Migraine (in Clinic)

Phase 2

Completed

• Conditions: Migraine Headache, With or Without Aura
• Interventions: Drug: Staccato Prochlorperazine 5 mg; Drug: Staccato Placebo; Drug: Staccato Prochlorperazine 10 mg

• Registration Number: NCT00610428
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

Brief Summary

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-01
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-08
• Results First Submitted: 2017-02-07
• Results First Submitted QC: 2017-06-17
• Last Update Submitted: 2017-06-17
• Results First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled PCZ 5 mg	Staccato Prochlorperazine 5 mg	Inhaled Staccato Prochlorperazine 5 mg
Inhaled Placebo	Staccato Placebo	Inhaled Staccato Placebo
Inhaled PCZ 10 mg	Staccato Prochlorperazine 10 mg	Inhaled Staccato Prochlorperazine 10 mg

Primary Outcome Measures

Name	Time	Method
Headache Pain Relief at 2 hr Post-dose by 2-point Definition	2 hours after treatment	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

Secondary Outcome Measures

Name	Time	Method
Survival Analysis for Time to Pain Relief	from treatment (time = 0) to 2 hours post treatment	Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition

Trial Locations

Locations (1)

Arthur H. Elkind, MD; 🇺🇸 Mount Vernon, New York, United States