Staccato Prochlorperazine in Patients With Migraine Headache

This study has been completed.
Sponsor:
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

January 28, 2008
January 28, 2008
March 2005
October 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Staccato Prochlorperazine in Patients With Migraine Headache
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Migraine Headache, With or Without Aura
  • Drug: Staccato Prochlorperazine
    Low dose
  • Drug: Staccato Prochlorperazine
    High dose
  • Drug: Staccato Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Staccato Prochlorperazine
  • Experimental: 2
    Intervention: Drug: Staccato Prochlorperazine
  • Placebo Comparator: 3
    Intervention: Drug: Staccato Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610428
AMDC-001-201, 6 June 2005 Amendment
No
Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc
Alexza Pharmaceuticals, Inc.
Not Provided
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
Alexza Pharmaceuticals, Inc.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP