Staccato Prochlorperazine in Patients With Migraine Headache
Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache, With or Without Aura
Intervention: Staccato Prochlorperazine (Drug); Staccato Prochlorperazine (Drug); Staccato Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Alexza Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): 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, Principal Investigator
Summary
Development of Staccato Prochlorperazine for the treatment of migraine headache.
Clinical Details
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Arthur H. Elkind, MD, Mount Vernon, New York 10550, United States
Additional Information
Starting date: March 2005
Last updated: January 28, 2008
|