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Staccato Prochlorperazine in Migraine (in Clinic)

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ClinicalTrials.gov Identifier: NCT00610428
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Brief Summary:
Development of Staccato Prochlorperazine for the treatment of migraine headache.

Condition or disease Intervention/treatment Phase
Migraine Headache, With or Without Aura Drug: Staccato Placebo Drug: Staccato Prochlorperazine 5 mg Drug: Staccato Prochlorperazine 10 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610428


Locations
United States, New York
Arthur H. Elkind, MD
Mount Vernon, New York, United States, 10550
Sponsors and Collaborators
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:
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00610428     History of Changes
Other Study ID Numbers: AMDC-001-201
First Posted: February 8, 2008    Key Record Dates
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018
Last Verified: January 2008
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexza Pharmaceuticals, Inc.:
Migraine, Staccato Prochlorperazine
Migraine headache with or without aura.

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Prochlorperazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action