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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine Headache, With or Without Aura
Interventions Drug: Staccato Placebo
Drug: Staccato Prochlorperazine 5 mg
Drug: Staccato Prochlorperazine 10 mg
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Hide Arm/Group Description

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg

Period Title: Overall Study
Started 24 24 27
Completed 24 23 25
Not Completed 0 1 2
Arm/Group Title Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg Total
Hide Arm/Group Description

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg

Total of all reporting groups
Overall Number of Baseline Participants 24 24 27 75
Hide Baseline Analysis Population Description
Safety Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 27 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
24
 100.0%
27
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 27 participants 75 participants
45  (11.4) 43.6  (10.8) 41.9  (10.1) 43.5  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 27 participants 75 participants
Female
15
  62.5%
20
  83.3%
23
  85.2%
58
  77.3%
Male
9
  37.5%
4
  16.7%
4
  14.8%
17
  22.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 27 participants 75 participants
24 24 27 75
1.Primary Outcome
Title Headache Pain Relief at 2 hr Post-dose by 2-point Definition
Hide Description 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
Time Frame 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with LOCF
Arm/Group Title Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Hide Arm/Group Description:

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg

Overall Number of Participants Analyzed 24 24 27
Measure Type: Count of Participants
Unit of Measure: Participants
6
  25.0%
11
  45.8%
13
  48.1%
2.Secondary Outcome
Title Survival Analysis for Time to Pain Relief
Hide Description Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition
Time Frame from treatment (time = 0) to 2 hours post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population by Treatment Assigned
Arm/Group Title Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Hide Arm/Group Description:

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg

Overall Number of Participants Analyzed 24 24 27
Mean (Standard Error)
Unit of Measure: minutes to pain relief
115.4  (4.92) 96.5  (8.22) 88.6  (8.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Placebo, Inhaled PCZ 5 mg
Comments Survival time is defined as time to the first successful headache relief.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0840
Comments p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)
Method Survival
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Placebo, Inhaled PCZ 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Survival time is defined as time to the first successful headache relief.
Statistical Test of Hypothesis P-Value 0.0383
Comments p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)
Method Survival
Comments [Not Specified]
Time Frame From informed consent through 30 days after last treatment
Adverse Event Reporting Description Adverse events (AE) observed by the Investigator or study personnel during study assessments and throughout post-dosing period or when volunteered by the patient regardless of treatment group or suspected causal relationship to study drugs were recorded on the AE CRF. The severity of the AE and relationship to study drug was determined by the investigator.
 
Arm/Group Title Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Hide Arm/Group Description

Inhaled Staccato Placebo

Staccato Placebo: Inhaled Staccato Placebo

Inhaled Staccato Prochlorperazine 5 mg

Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg

Inhaled Staccato Prochlorperazine 10 mg

Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg

All-Cause Mortality
Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 10 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/24 (33.33%)      12/24 (50.00%)      16/27 (59.26%)    
Eye disorders       
Lacrimation Increased  1  2/24 (8.33%)  2 1/24 (4.17%)  1 3/27 (11.11%)  3
Gastrointestinal disorders       
Dysgeusia  1  2/24 (8.33%)  2 7/24 (29.17%)  7 5/27 (18.52%)  5
Nervous system disorders       
Somnolence  1  2/24 (8.33%)  2 4/24 (16.67%)  4 3/27 (11.11%)  3
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/24 (4.17%)  1 4/24 (16.67%)  4 2/27 (7.41%)  2
Throat Irritation  1  2/24 (8.33%)  2 3/24 (12.50%)  3 4/27 (14.81%)  4
1
Term from vocabulary, MedDRA (8.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Executive VP, Research & Development, Regulatory & Quality
Organization: Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00610428     History of Changes
Other Study ID Numbers: AMDC-001-201
First Submitted: January 28, 2008
First Posted: February 8, 2008
Results First Submitted: February 7, 2017
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018