Staccato Prochlorperazine in Migraine (in Clinic)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-10-31

Brief Summary

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Development of Staccato Prochlorperazine for the treatment of migraine headache.

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Detailed Description

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Conditions

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Migraine Headache, With or Without Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled Placebo

Inhaled Staccato Placebo

Group Type PLACEBO_COMPARATOR

Staccato Placebo

Intervention Type DRUG

Inhaled Staccato Placebo

Inhaled PCZ 5 mg

Inhaled Staccato Prochlorperazine 5 mg

Group Type EXPERIMENTAL

Staccato Prochlorperazine 5 mg

Intervention Type DRUG

Inhaled Prochlorperazine 5 mg

Inhaled PCZ 10 mg

Inhaled Staccato Prochlorperazine 10 mg

Group Type PLACEBO_COMPARATOR

Staccato Prochlorperazine 10 mg

Intervention Type DRUG

Inhaled Prochlorperazine10 mg

Interventions

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Staccato Placebo

Inhaled Staccato Placebo

Intervention Type DRUG

Staccato Prochlorperazine 5 mg

Inhaled Prochlorperazine 5 mg

Intervention Type DRUG

Staccato Prochlorperazine 10 mg

Inhaled Prochlorperazine10 mg

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes