Trial Outcomes & Findings for Staccato Prochlorperazine in Migraine (Out Patient) (NCT NCT00422812)
NCT ID: NCT00422812
Last Updated: 2018-01-25
Results Overview
Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
400 participants
Primary outcome timeframe
2 hr post-dose
Results posted on
2018-01-25
Participant Flow
Participant milestones
| Measure |
Inhaled Placebo
Inhaled Staccato Placebo
Inhaled Placebo: Inhaled Staccato Placebo
|
Inhaled PCZ 5 mg
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg
|
Inhaled PCZ 7.5 mg
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg
|
Inhaled PCZ 10 mg
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
104
|
93
|
105
|
|
Overall Study
COMPLETED
|
98
|
103
|
91
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Staccato Prochlorperazine in Migraine (Out Patient)
Baseline characteristics by cohort
| Measure |
Inhaled Placebo
n=98 Participants
Inhaled Staccato Placebo
Inhaled Placebo: Inhaled Staccato Placebo
|
Inhaled PCZ 5 mg
n=104 Participants
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg
|
Inhaled PCZ 7.5 mg
n=93 Participants
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg
|
Inhaled PCZ 10 mg
n=105 Participants
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
395 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
349 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
104 participants
n=7 Participants
|
93 participants
n=5 Participants
|
105 participants
n=4 Participants
|
400 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hr post-dosePopulation: ITT w/ LOCF Population
Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),
Outcome measures
| Measure |
Inhaled Placebo
n=98 Participants
Inhaled Staccato Placebo
Inhaled Placebo: Inhaled Staccato Placebo
|
Inhaled PCZ 5 mg
n=103 Participants
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg
|
Inhaled PCZ 7.5 mg
n=91 Participants
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg
|
Inhaled PCZ 10 mg
n=103 Participants
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg
|
|---|---|---|---|---|
|
Headache Pain Relief at 2 hr
|
40 Participants
|
62 Participants
|
58 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: ITT w/ LOCF Population
Percentage of Responders, Pain-Free, by Treatment Group over Time
Outcome measures
| Measure |
Inhaled Placebo
n=98 Participants
Inhaled Staccato Placebo
Inhaled Placebo: Inhaled Staccato Placebo
|
Inhaled PCZ 5 mg
n=103 Participants
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg
|
Inhaled PCZ 7.5 mg
n=91 Participants
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg
|
Inhaled PCZ 10 mg
n=103 Participants
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg
|
|---|---|---|---|---|
|
Responders, Pain-Free at 2 Hours
|
15 Participants
|
22 Participants
|
27 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 0 to 4 hoursPopulation: ITT Population
Survival for time to the first successful headache pain relief by Pain-IHS definition over the 0 to 4 hr period by treatment assigned. Pairwise comparisons were made for each of the 3 active doses to placebo. Survival Analysis (Kaplan-Meyer) was included to evaluate treatment efficacy over the 0 to 4 hr period. All tests were 2-sided with a p-value at α=0.05.
Outcome measures
| Measure |
Inhaled Placebo
n=103 Participants
Inhaled Staccato Placebo
Inhaled Placebo: Inhaled Staccato Placebo
|
Inhaled PCZ 5 mg
n=91 Participants
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg
|
Inhaled PCZ 7.5 mg
n=103 Participants
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg
|
Inhaled PCZ 10 mg
n=98 Participants
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg
|
|---|---|---|---|---|
|
Survival of Headache Pain Relief
|
77 Participants
|
67 Participants
|
71 Participants
|
52 Participants
|
Adverse Events
Inhaled Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Inhaled PCZ 5 mg
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Inhaled PCZ 7.5 mg
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Inhaled PCZ 10 mg
Serious events: 0 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inhaled Placebo
n=98 participants at risk
Inhaled Staccato Placebo
Inhaled Placebo: Inhaled Staccato Placebo
|
Inhaled PCZ 5 mg
n=104 participants at risk
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg
|
Inhaled PCZ 7.5 mg
n=93 participants at risk
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg
|
Inhaled PCZ 10 mg
n=105 participants at risk
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
3.1%
3/98 • Number of events 3 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
5.8%
6/104 • Number of events 6 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
6.5%
6/93 • Number of events 6 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
3.8%
4/105 • Number of events 4 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Nervous system disorders
Dizziness
|
4.1%
4/98 • Number of events 4 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
0.00%
0/104 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
3.2%
3/93 • Number of events 3 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
8.6%
9/105 • Number of events 9 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Nervous system disorders
Somnolence
|
1.0%
1/98 • Number of events 1 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
8.7%
9/104 • Number of events 9 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
9.7%
9/93 • Number of events 9 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
5.7%
6/105 • Number of events 6 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Nervous system disorders
Psychiatric Disorders
|
1.0%
1/98 • Number of events 1 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
2.9%
3/104 • Number of events 3 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
1.1%
1/93 • Number of events 1 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
7.6%
8/105 • Number of events 8 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/98 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
19.2%
20/104 • Number of events 20 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
16.1%
15/93 • Number of events 15 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
30.5%
32/105 • Number of events 32 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/98 • Number of events 1 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
1.9%
2/104 • Number of events 2 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
3.2%
3/93 • Number of events 3 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
8.6%
9/105 • Number of events 9 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/98 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
3.8%
4/104 • Number of events 4 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
6.5%
6/93 • Number of events 6 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
4.8%
5/105 • Number of events 5 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Irritation
|
1.0%
1/98 • Number of events 1 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
3.8%
4/104 • Number of events 4 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
4.3%
4/93 • Number of events 4 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
4.8%
5/105 • Number of events 5 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
1.0%
1/98 • Number of events 1 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
18.3%
19/104 • Number of events 19 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
21.5%
20/93 • Number of events 20 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
29.5%
31/105 • Number of events 31 • From dosing (0 hours) through 24 hours
Patient self- assessment for adverse events via Patient Diary over 0-24 hours at 7 specified time points
|
Additional Information
Executive VP, Research & Development, Regulatory & Quality
Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60