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Staccato Loxapine in Migraine (in Clinic)

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: NCT00489476
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : April 24, 2017
Last Update Posted : July 6, 2017
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
Interventions Drug: Staccato Loxapine
Drug: Staccato Placebo
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Hide Arm/Group Description

Staccato Placebo, 0 mg

Staccato Placebo: Placebo aerosol inhalation (0mg)

1.25 mg ADASUVE, single dose

Staccato Loxapine

2.5 mg ADASUVE, single dose

Staccato Loxapine

5 mg ADASUVE, single dose

Staccato Loxapine

Period Title: Overall Study
Started 39 43 43 43
Completed 39 42 43 43
Not Completed 0 1 0 0
Reason Not Completed
Lost to Follow-up             0             1             0             0
Arm/Group Title Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine Total
Hide Arm/Group Description

Staccato Placebo, 0 mg

Staccato Placebo: Placebo aerosol inhalation (0mg)

1.25 mg ADASUVE, single dose

Staccato Loxapine

2.5 mg ADASUVE, single dose

Staccato Loxapine

5 mg ADASUVE, single dose

Staccato Loxapine

Total of all reporting groups
Overall Number of Baseline Participants 39 43 43 43 168
Hide Baseline Analysis Population Description
Safety Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 43 participants 43 participants 43 participants 168 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
43
 100.0%
43
 100.0%
43
 100.0%
168
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 43 participants 43 participants 43 participants 168 participants
42.2  (10.94) 41.7  (13.09) 38.5  (11.89) 42.3  (12.68) 41.1  (2.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 43 participants 43 participants 43 participants 168 participants
Female
29
  74.4%
38
  88.4%
32
  74.4%
35
  81.4%
134
  79.8%
Male
10
  25.6%
5
  11.6%
11
  25.6%
8
  18.6%
34
  20.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 43 participants 43 participants 43 participants 168 participants
39 43 43 43 168
1.Primary Outcome
Title Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours
Hide Description

The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD.

Intent to treat (ITT) with last observation carried forward (LOCF)

Time Frame Baseline and 2 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with LOCF
Arm/Group Title Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Hide Arm/Group Description:

Staccato Placebo, 0 mg

Staccato Placebo: Placebo aerosol inhalation (0mg)

1.25 mg ADASUVE, single dose

Staccato Loxapine

2.5 mg ADASUVE, single dose

Staccato Loxapine

5 mg ADASUVE, single dose

Staccato Loxapine

Overall Number of Participants Analyzed 39 43 43 43
Measure Type: Number
Unit of Measure: participants
20 29 34 33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Staccato Placebo, 5 mg Staccato Loxapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0212
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Staccato Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0106
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Pain-free at 2 Hours
Hide Description Pain-free (Pain-IHS) at the 2 hour time point
Time Frame Baseline and 2 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with LOCF Population
Arm/Group Title Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Hide Arm/Group Description:

Staccato Placebo, 0 mg

Staccato Placebo: Placebo aerosol inhalation (0mg)

1.25 mg ADASUVE, single dose

Staccato Loxapine

2.5 mg ADASUVE, single dose

Staccato Loxapine

5 mg ADASUVE, single dose

Staccato Loxapine

Overall Number of Participants Analyzed 39 43 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.7%
12
  27.9%
13
  30.2%
9
  20.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Staccato Placebo, 2.5 mg Staccato Loxapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Staccato Placebo, 1.25 mg Staccato Loxapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Responders, Sustained Freedom From Pain
Hide Description The percentages of patients with sustained freedom from pain (pain-free at 2 hours after dosing with no rescue medication and no recurrence of headache from 2 to 24 hours)
Time Frame Baseline through 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with LOCF Population
Arm/Group Title Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Hide Arm/Group Description:

Staccato Placebo, 0 mg

Staccato Placebo: Placebo aerosol inhalation (0mg)

1.25 mg ADASUVE, single dose

Staccato Loxapine

2.5 mg ADASUVE, single dose

Staccato Loxapine

5 mg ADASUVE, single dose

Staccato Loxapine

Overall Number of Participants Analyzed 39 43 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.7%
9
  20.9%
11
  25.6%
7
  16.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Staccato Placebo, 2.5 mg Staccato Loxapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0409
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
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 Adverse events (AEs) were assessed at 9 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
 
Arm/Group Title Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Hide Arm/Group Description

Staccato Placebo, 0 mg

Staccato Placebo: Placebo aerosol inhalation (0mg)

1.25 mg ADASUVE, single dose

Staccato Loxapine

2.5 mg ADASUVE, single dose

Staccato Loxapine

5 mg ADASUVE, single dose

Staccato Loxapine

All-Cause Mortality
Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/43 (0.00%)      0/43 (0.00%)      0/43 (0.00%)    
Hide Serious Adverse Events
Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/43 (0.00%)      0/43 (0.00%)      0/43 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Staccato Placebo 1.25 mg Staccato Loxapine 2.5 mg Staccato Loxapine 5 mg Staccato Loxapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/39 (35.90%)      18/43 (41.86%)      21/43 (48.84%)      27/43 (62.79%)    
Gastrointestinal disorders         
Dry Mouth  1  2/39 (5.13%)  2 1/43 (2.33%)  1 2/43 (4.65%)  2 2/43 (4.65%)  2
Dysgeusia  1  5/39 (12.82%)  5 8/43 (18.60%)  8 10/43 (23.26%)  10 16/43 (37.21%)  16
Hypoaesthesia Oral  1  0/39 (0.00%)  0 1/43 (2.33%)  1 2/43 (4.65%)  2 1/43 (2.33%)  1
Oral Discomfort  1  1/39 (2.56%)  1 0/43 (0.00%)  0 1/43 (2.33%)  1 3/43 (6.98%)  3
General disorders         
Fatigue  1  3/39 (7.69%)  3 0/43 (0.00%)  0 3/43 (6.98%)  3 6/43 (13.95%)  6
Nervous system disorders         
Disturbance in Attention  1  0/39 (0.00%)  0 2/43 (4.65%)  2 0/43 (0.00%)  0 1/43 (2.33%)  1
Dizziness  1  2/39 (5.13%)  2 1/43 (2.33%)  1 3/43 (6.98%)  3 1/43 (2.33%)  1
Somnolence  1  5/39 (12.82%)  5 2/43 (4.65%)  2 10/43 (23.26%)  10 10/43 (23.26%)  10
Respiratory, thoracic and mediastinal disorders         
Pharyngeal Hypoaesthesia  1  0/39 (0.00%)  0 0/43 (0.00%)  0 0/43 (0.00%)  0 3/43 (6.98%)  3
Throat Irritation  1  0/39 (0.00%)  0 3/43 (6.98%)  3 0/43 (0.00%)  0 0/43 (0.00%)  0
Vascular disorders         
Hypotension  1  1/39 (2.56%)  1 0/43 (0.00%)  0 1/43 (2.33%)  1 2/43 (4.65%)  2
1
Term from vocabulary, MedDRA (10.0)
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
Layout table for Results Point of Contact information
Name/Title: Executive VP, Research & Development, Regulatory & Quality
Organization: Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
EMail: ClinicalTrialsInfo@alexza.com
Layout table for additonal information
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00489476    
Other Study ID Numbers: AMDC-104-201
First Submitted: June 20, 2007
First Posted: June 21, 2007
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: July 6, 2017