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Staccato Prochlorperazine in Migraine (in Clinic)

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ClinicalTrials.gov Identifier: NCT00610428
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

January 28, 2008
February 8, 2008
February 7, 2017
January 25, 2018
January 25, 2018
March 2005
October 2005   (Final data collection date for primary outcome measure)
Headache Pain Relief at 2 hr Post-dose by 2-point Definition [ Time Frame: 2 hours after treatment ]
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
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 ]
Complete list of historical versions of study NCT00610428 on ClinicalTrials.gov Archive Site
Survival Analysis for Time to Pain Relief [ Time Frame: from treatment (time = 0) to 2 hours post treatment ]
Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition
Not Provided
Not Provided
Not Provided
 
Staccato Prochlorperazine in Migraine (in Clinic)
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Migraine Headache, With or Without Aura
  • Drug: Staccato Placebo
    Inhaled Staccato Placebo
  • Drug: Staccato Prochlorperazine 5 mg
    Inhaled Prochlorperazine 5 mg
  • Drug: Staccato Prochlorperazine 10 mg
    Inhaled Prochlorperazine10 mg
  • Placebo Comparator: Inhaled Placebo
    Inhaled Staccato Placebo
    Intervention: Drug: Staccato Placebo
  • Experimental: Inhaled PCZ 5 mg
    Inhaled Staccato Prochlorperazine 5 mg
    Intervention: Drug: Staccato Prochlorperazine 5 mg
  • Placebo Comparator: Inhaled PCZ 10 mg
    Inhaled Staccato Prochlorperazine 10 mg
    Intervention: Drug: Staccato Prochlorperazine 10 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00610428
AMDC-001-201
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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