Migraine Headache, With or Without Aura Clinical Trial
Official title:
A Multi-center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
Verified date | January 2008 |
Source | Alexza Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Development of Staccato Prochlorperazine for the treatment of migraine headache.
Status | Completed |
Enrollment | 75 |
Est. completion date | October 2005 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Arthur H. Elkind, MD | Mount Vernon | New York |
Lead Sponsor | Collaborator |
---|---|
Alexza Pharmaceuticals, Inc. |
United States,
Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache Pain Relief at 2 hr Post-dose by 2-point Definition | patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain | 2 hours after treatment | |
Secondary | Survival Analysis for Time to Pain Relief | Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition | from treatment (time = 0) to 2 hours post treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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N/A |