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| Study 1 of 594 for search of: | received on or after 01/16/2009 |
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| Sponsored by: |
Alexza Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Alexza Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00825500 |
Purpose
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headache |
Drug: High dose Drug: Low dose Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache |
| Estimated Enrollment: | 360 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: High dose
Staccato Loxapine 2.5 mg
|
| 2: Active Comparator |
Drug: Low dose
Staccato Loxapine 1.25 mg
|
| 3: Placebo Comparator |
Drug: Placebo
Staccato Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Robert S Fishman, MD | 650 944 7048 | rfishman@alexza.com |
| Contact: Daniel A Spyker, MD | 650 944 7272 | dspyker@alexza.com |
| United States, Missouri | |
| Roger K. Cady | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Roger K. Cady, MD 417-883-7889 dmilligan@clinvest.com | |
| Principal Investigator: Roger K. Cady | |
| United States, New York | |
| Elkind Headache Center | Recruiting |
| Mount Vernon, New York, United States, 10550 | |
| Contact: Arthur Elkind, MD 914-667-2230 arthur.elkind@verizon.net | |
| Principal Investigator: Arthur Elkind, MD | |
| United States, Rhode Island | |
| CNS Research, Inc. | Recruiting |
| East Providence, Rhode Island, United States, 02916 | |
| Contact: Peter J. Bellafiore, MD 800-707-6013 axel@cns-research.com | |
| Principal Investigator: Peter J. Bellafiore, MD | |
| Principal Investigator: | Roger K. Cady, MD | Clinvest/A Division of Banyan Group, Inc. |
| Principal Investigator: | Peter J. Bellafiore, MD | CNS Research, Inc. |
| Principal Investigator: | Arthur Elkind, MD | Elkind Headache Center |
More Information
| Responsible Party: | Alexza Pharmaceuticals, Inc. ( Robert S. Fishman, MD ) |
| Study ID Numbers: | AMDC-104-202, 24-October-2008 |
| Study First Received: | January 19, 2009 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00825500 |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine headache Loxapine Staccato |
|
Signs and Symptoms Dopamine Migraine Disorders Headache Loxapine Central Nervous System Diseases |
Neurologic Manifestations Headache Disorders, Primary Pain Brain Diseases Headache Disorders |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Therapeutic Uses Dopamine Agents Central Nervous System Agents |
