Staccato Prochlorperazine in Patients With Migraine Headache
This study has been completed.
Sponsor:
Alexza Pharmaceuticals, Inc.
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00610428
First received: January 28, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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Purpose
Development of Staccato Prochlorperazine for the treatment of migraine headache.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headache, With or Without Aura |
Drug: Staccato Prochlorperazine Drug: Staccato Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hemiplegic migraine
Drug Information available for:
Prochlorperazine
Prochlorperazine maleate
Prochlorperazine edisylate
U.S. FDA Resources
Further study details as provided by Alexza Pharmaceuticals, Inc.:
Primary Outcome Measures:
- patient headache pain as measured on the scale: 0=NO headache pain, to 3=severe headache pain Measure: 1 = MILD headache pain Measure: 2 = MODERATE headache pain Measure: 3 = SEVERE headac [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | March 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Staccato Prochlorperazine
High dose
|
| Experimental: 2 |
Drug: Staccato Prochlorperazine
Low dose
|
| Placebo Comparator: 3 |
Drug: Staccato Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00610428 History of Changes |
| Other Study ID Numbers: | AMDC-001-201, 6 June 2005 Amendment |
| Study First Received: | January 28, 2008 |
| Last Updated: | January 28, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alexza Pharmaceuticals, Inc.:
|
Migraine, Staccato Prochlorperazine Migraine headache with or without aura. |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Prochlorperazine Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013