Migraine Headache, With or Without Aura
Conditions
Keywords
Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.
Brief summary
Development of Staccato Prochlorperazine for the treatment of migraine headache.
Interventions
DRUGStaccato Placebo
Inhaled Staccato Placebo
DRUGStaccato Prochlorperazine 5 mg
Inhaled Prochlorperazine 5 mg
DRUGStaccato Prochlorperazine 10 mg
Inhaled Prochlorperazine10 mg
Sponsors
Alexza Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Pain Relief at 2 hr Post-dose by 2-point Definition | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Analysis for Time to Pain Relief | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Placebo Inhaled Staccato Placebo
Staccato Placebo: Inhaled Staccato Placebo | 24 |
| Inhaled PCZ 5 mg Inhaled Staccato Prochlorperazine 5 mg
Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg | 24 |
| Inhaled PCZ 10 mg Inhaled Staccato Prochlorperazine 10 mg
Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg | 27 |
| Total | 75 |
Baseline characteristics
| Characteristic | Inhaled PCZ 5 mg | Inhaled PCZ 10 mg | Inhaled Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 27 Participants | 24 Participants | 75 Participants |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 10.8 | 41.9 years STANDARD_DEVIATION 10.1 | 45 years STANDARD_DEVIATION 11.4 | 43.5 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 24 participants | 27 participants | 24 participants | 75 participants |
| Sex: Female, Male Female | 20 Participants | 23 Participants | 15 Participants | 58 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 8 / 24 | 12 / 24 | 16 / 27 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 27 |
Outcome results
Primary
Headache Pain Relief at 2 hr Post-dose by 2-point Definition
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
Population: ITT Population with LOCF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inhaled Placebo | Headache Pain Relief at 2 hr Post-dose by 2-point Definition | 6 Participants |
| Inhaled PCZ 5 mg | Headache Pain Relief at 2 hr Post-dose by 2-point Definition | 11 Participants |
| Inhaled PCZ 10 mg | Headache Pain Relief at 2 hr Post-dose by 2-point Definition | 13 Participants |
Secondary
Survival Analysis for Time to Pain Relief
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
Population: ITT Population by Treatment Assigned
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Placebo | Survival Analysis for Time to Pain Relief | 115.4 minutes to pain relief | Standard Error 4.92 |
| Inhaled PCZ 5 mg | Survival Analysis for Time to Pain Relief | 96.5 minutes to pain relief | Standard Error 8.22 |
| Inhaled PCZ 10 mg | Survival Analysis for Time to Pain Relief | 88.6 minutes to pain relief | Standard Error 8.33 |
Comparison: Survival time is defined as time to the first successful headache relief.p-value: 0.084Survival
p-value: 0.0383Survival