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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
Show 25 Study Locations
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. |
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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 |