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Staccato Prochlorperazine in Migraine (in Clinic)

Primary Purpose

Migraine Headache, With or Without Aura

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Staccato Placebo

Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 10 mg

About this trial

This is an interventional treatment trial for Migraine Headache, With or Without Aura focused on measuring Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arthur H. Elkind, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Inhaled Placebo

Inhaled PCZ 5 mg

Inhaled PCZ 10 mg

Arm Description

Inhaled Staccato Placebo

Inhaled Staccato Prochlorperazine 5 mg

Inhaled Staccato Prochlorperazine 10 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival Analysis for Time to Pain Relief

Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition

Full Information

NCT ID

NCT00610428

First Posted

January 28, 2008

Last Updated

June 17, 2017

Sponsor

Alexza Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00610428

Brief Title

Staccato Prochlorperazine in Migraine (in Clinic)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexza Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Development of Staccato Prochlorperazine for the treatment of migraine headache.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Headache, With or Without Aura

Keywords

Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled Placebo

Arm Type

Placebo Comparator

Arm Description

Inhaled Staccato Placebo

Arm Title

Inhaled PCZ 5 mg

Arm Type

Experimental

Arm Description

Inhaled Staccato Prochlorperazine 5 mg

Arm Title

Inhaled PCZ 10 mg

Arm Type

Placebo Comparator

Arm Description

Inhaled Staccato Prochlorperazine 10 mg

Intervention Type

Drug

Intervention Name(s)

Staccato Placebo

Intervention Description

Inhaled Staccato Placebo

Intervention Type

Drug

Intervention Name(s)

Staccato Prochlorperazine 5 mg

Intervention Description

Inhaled Prochlorperazine 5 mg

Intervention Type

Drug

Intervention Name(s)

Staccato Prochlorperazine 10 mg

Intervention Description

Inhaled Prochlorperazine10 mg

Primary Outcome Measure Information:

Title

Headache Pain Relief at 2 hr Post-dose by 2-point Definition

Description

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

Time Frame

2 hours after treatment

Secondary Outcome Measure Information:

Title

Survival Analysis for Time to Pain Relief

Description

Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition

Time Frame

from treatment (time = 0) to 2 hours post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: