Staccato Prochlorperazine in Migraine (in Clinic)

June 17, 2017 updated by: Alexza Pharmaceuticals, Inc.

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

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mount Vernon, New York, United States, 10550
        • Arthur H. Elkind, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Inhaled Placebo
Inhaled Staccato Placebo
Drug: Staccato Placebo
Inhaled Staccato Placebo
Experimental: Inhaled PCZ 5 mg
Inhaled Staccato Prochlorperazine 5 mg
Drug: Staccato Prochlorperazine 5 mg
Inhaled Prochlorperazine 5 mg
Placebo Comparator: Inhaled PCZ 10 mg
Inhaled Staccato Prochlorperazine 10 mg
Drug: Staccato Prochlorperazine 10 mg
Inhaled Prochlorperazine10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Pain Relief at 2 hr Post-dose by 2-point Definition
Time Frame: 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
2 hours after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Analysis for Time to Pain Relief
Time Frame: 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
from treatment (time = 0) to 2 hours post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Sheena Auroa, MD
  • Principal Investigator: Roger K Cady, MD
  • Principal Investigator: Arthur Elkind, MD
  • Principal Investigator: Fred Freitag, DO
  • Principal Investigator: Lisa Mannix, MD
  • Principal Investigator: Niana T Mathew, MD
  • Principal Investigator: Egilius LH Spierings, MD
  • Principal Investigator: Stewart Tepper, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDC-001-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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