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| Sponsor: | Alexza Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Alexza Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00422812 |
Purpose
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headache Aura |
Drug: Prochlorperazine thermal aerosol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose, Efficacy and Safety Outpatient Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Department of Neurology, Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| California Medical Clinic for Headache | |
| Santa Monica, California, United States, 90404 | |
| Neurological Research Institute of East Bay | |
| Walnut Creek, California, United States, 94596 | |
| San Francisco Headache Clinic | |
| San Francisco, California, United States, 94109 | |
| United States, Colorado | |
| Mile High Research Center | |
| Denver, Colorado, United States, 80218-1110 | |
| United States, Connecticut | |
| The New England Center for Headache | |
| Stamford,, Connecticut, United States, 06902 | |
| Associated Neurologists of Southern Connecticut PC | |
| Fairfield, Connecticut, United States, 06824 | |
| Hartford Headache Center | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Florida | |
| MD Clinical | |
| Hallandale Beach, Florida, United States, 33009 | |
| Palm Beach Neurological Center | |
| West Palm Beach, Florida, United States, 33410 | |
| United States, Illinois | |
| Diamond Headache Clinic | |
| Chicago, Illinois, United States, 60614-1726 | |
| United States, Massachusetts | |
| Medvadis | |
| Wellesley Hills, Massachusetts, United States, 02481-2106 | |
| New England Regional Headache Center | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| The Michigan Head-Pain and Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104.5199 | |
| United States, Missouri | |
| Headache Care Center Primary Care Network, INC | |
| Springfield, Missouri, United States, 65807 | |
| United States, New York | |
| Elkind Headache Center | |
| Mt. Vernon, New York, United States, 10050 | |
| Regional Clinical Research | |
| Endwell, New York, United States, 13760 | |
| New York Headache Center | |
| New York, New York, United States, 10021 | |
| Island Neurological Associates, PC | |
| Plainview, New York, United States, 11803 | |
| United States, North Carolina | |
| PharmQuest | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Ohio | |
| ClinExcel Research | |
| West Chester, Ohio, United States, 45069 | |
| Health Research Associates | |
| Cleveland, Ohio, United States, 44121 | |
| United States, Oklahoma | |
| University Neurologists/OUHSC | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Texas | |
| Houston Headache Clinic | |
| Houston, Texas, United States, 77004 | |
| United States, Washington | |
| Swedish Research Center | |
| Seattle, Washington, United States, 98104 | |
More Information
| Responsible Party: | Alexza Pharmaceuticals, Inc. ( Dan Spyker ) |
| Study ID Numbers: | AMDC-001-202 |
| Study First Received: | January 12, 2007 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00422812 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine, Staccato Prochlorperazine Migraine headache with or without aura. |
|
Prochlorperazine Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Antiemetics Headache Disorders, Primary Pain Brain Diseases Headache Disorders Signs and Symptoms Migraine Disorders Therapeutic Uses Headache |
Tranquilizing Agents Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Autonomic Agents Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |