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Staccato Loxapine in Migraine (Out Patient)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00825500
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Drug: Inhaled Placebo
Drug: Inhaled Loxapine 1.25 mg
Drug: Inhaled Loxapine 2.5 mg
Enrollment 366
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Hide Arm/Group Description

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Period Title: Overall Study
Started 125 121 120
Completed 125 121 120
Not Completed 0 0 0
Arm/Group Title Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg Total
Hide Arm/Group Description

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

 Total of all reporting groups
Overall Number of Baseline Participants 125 121 120 366
Hide Baseline Analysis Population Description
Safety Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 121 participants 120 participants 366 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
125
 100.0%
121
 100.0%
120
 100.0%
366
 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 125 participants 121 participants 120 participants 366 participants
41.5  (12.14) 41.2  (12.19) 42  (12.74) 41.5  (12.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 121 participants 120 participants 366 participants
Female
88
  70.4%
100
  82.6%
41
  34.2%
229
  62.6%
Male
37
  29.6%
21
  17.4%
79
  65.8%
137
  37.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 125 participants 121 participants 120 participants 366 participants
125 121 120 366
1.Primary Outcome
Title Pain-Relief at 2 Hours Post-treatment
Hide Description Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with LOCF Population
Arm/Group Title Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Hide Arm/Group Description:

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Overall Number of Participants Analyzed 124 121 119
Measure Type: Count of Participants
Unit of Measure: Participants
56
  45.2%
65
  53.7%
66
  55.5%
2.Secondary Outcome
Title Photophobia Free
Hide Description Free of Photophobia at 2 Hours Post-treatment
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with LOCF Population
Arm/Group Title Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Hide Arm/Group Description:

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Overall Number of Participants Analyzed 124 121 119
Measure Type: Count of Participants
Unit of Measure: Participants
59
  47.6%
47
  38.8%
54
  45.4%
Time Frame Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse Event Reporting Description Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary
 
Arm/Group Title Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Hide Arm/Group Description

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
All-Cause Mortality
Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)      0/121 (0.00%)      0/120 (0.00%)    
Hide Serious Adverse Events
Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/125 (0.00%)      0/121 (0.00%)      0/120 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inhaled Placebo Inhaled Loxapine 1.25 mg Inhaled Loxapine 2.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/125 (17.60%)      27/121 (22.31%)      24/120 (20.00%)    
Gastrointestinal disorders       
Dysgeusia † 1  6/125 (4.80%)  6 16/121 (13.22%)  16 10/120 (8.33%)  10
Nervous system disorders       
Dizziness † 1  12/125 (9.60%)  12 8/121 (6.61%)  8 6/120 (5.00%)  6
Somnolence † 1  4/125 (3.20%)  4 3/121 (2.48%)  3 8/120 (6.67%)  8
1
Term from vocabulary, MedDRA (10.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: Alexza Pharmaceuticals, Inc
Phone: 650.944.7777
EMail: jcassella@alexza.com
Layout table for additonal information
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00825500    
Other Study ID Numbers: AMDC-104-202
24-October-2008
First Submitted: January 19, 2009
First Posted: January 21, 2009
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017