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Completed

NCT Number: NCT00610428

Staccato Prochlorperazine in Migraine (in Clinic)

Development of Staccato Prochlorperazine for the treatment of migraine headache.

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Key information

Conditions

Migraine Headache, With or Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arthur H. Elkind, MD

Mount Vernon, New York, 10550, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Staccato Placebo

Drug

Inhaled Staccato Placebo

Staccato Prochlorperazine 5 mg

Drug

Inhaled Prochlorperazine 5 mg

Staccato Prochlorperazine 10 mg

Drug

Inhaled Prochlorperazine10 mg

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Feb 8, 2008
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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