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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 |
| Enrollment: | 366 |
| Study Start Date: | January 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 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| United States, Missouri | |
| Roger K. Cady | |
| Springfield, Missouri, United States, 65807 | |
| United States, New York | |
| Elkind Headache Center | |
| Mount Vernon, New York, United States, 10550 | |
| United States, Rhode Island | |
| CNS Research, Inc. | |
| East Providence, Rhode Island, United States, 02916 | |
| 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: | August 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00825500 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine headache Loxapine Staccato |
|
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Diseases Central Nervous System Depressants Pain Headache Disorders, Primary Brain Diseases Antipsychotic Agents |
Headache Disorders Signs and Symptoms Dopamine Migraine Disorders Headache Loxapine Neurologic Manifestations Dopamine Agents |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs Central Nervous System Depressants Central Nervous System Diseases Dopamine Antagonists Pain Headache Disorders, Primary Brain Diseases |
Antipsychotic Agents Pharmacologic Actions Headache Disorders Signs and Symptoms Migraine Disorders Therapeutic Uses Headache Loxapine Neurologic Manifestations Dopamine Agents Central Nervous System Agents |
