Trial Outcomes & Findings for Staccato Prochlorperazine in Migraine (in Clinic) (NCT NCT00610428)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

2 hours after treatment

Results posted on

2018-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Inhaled Placebo Inhaled Staccato Placebo Staccato Placebo: Inhaled Staccato Placebo	Inhaled PCZ 5 mg Inhaled Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg	Inhaled PCZ 10 mg Inhaled Staccato Prochlorperazine 10 mg Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg
Overall Study STARTED	24	24	27
Overall Study COMPLETED	24	23	25
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Staccato Prochlorperazine in Migraine (in Clinic)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhaled Placebo n=24 Participants Inhaled Staccato Placebo Staccato Placebo: Inhaled Staccato Placebo	Inhaled PCZ 5 mg n=24 Participants Inhaled Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg	Inhaled PCZ 10 mg n=27 Participants Inhaled Staccato Prochlorperazine 10 mg Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg	Total n=75 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
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	75 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	45 years STANDARD_DEVIATION 11.4 • n=5 Participants	43.6 years STANDARD_DEVIATION 10.8 • n=7 Participants	41.9 years STANDARD_DEVIATION 10.1 • n=5 Participants	43.5 years STANDARD_DEVIATION 10.7 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	58 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	27 participants n=5 Participants	75 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 hours after treatment

Population: ITT Population with LOCF

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

Outcome measures

Outcome measures
Measure	Inhaled Placebo n=24 Participants Inhaled Staccato Placebo Staccato Placebo: Inhaled Staccato Placebo	Inhaled PCZ 5 mg n=24 Participants Inhaled Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg	Inhaled PCZ 10 mg n=27 Participants Inhaled Staccato Prochlorperazine 10 mg Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg
Headache Pain Relief at 2 hr Post-dose by 2-point Definition	6 Participants	11 Participants	13 Participants

SECONDARY outcome

Timeframe: from treatment (time = 0) to 2 hours post treatment

Population: ITT Population by Treatment Assigned

Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition

Outcome measures

Outcome measures
Measure	Inhaled Placebo n=24 Participants Inhaled Staccato Placebo Staccato Placebo: Inhaled Staccato Placebo	Inhaled PCZ 5 mg n=24 Participants Inhaled Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg	Inhaled PCZ 10 mg n=27 Participants Inhaled Staccato Prochlorperazine 10 mg Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg
Survival Analysis for Time to Pain Relief	115.4 minutes to pain relief Standard Error 4.92	96.5 minutes to pain relief Standard Error 8.22	88.6 minutes to pain relief Standard Error 8.33

Adverse Events

Inhaled Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Inhaled PCZ 5 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Inhaled PCZ 10 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Inhaled Placebo n=24 participants at risk Inhaled Staccato Placebo Staccato Placebo: Inhaled Staccato Placebo	Inhaled PCZ 5 mg n=24 participants at risk Inhaled Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg	Inhaled PCZ 10 mg n=27 participants at risk Inhaled Staccato Prochlorperazine 10 mg Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg
Eye disorders Lacrimation Increased	8.3% 2/24 • Number of events 2 • From informed consent through 30 days after last treatment 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.	4.2% 1/24 • Number of events 1 • From informed consent through 30 days after last treatment 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.	11.1% 3/27 • Number of events 3 • From informed consent through 30 days after last treatment 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.
Gastrointestinal disorders Dysgeusia	8.3% 2/24 • Number of events 2 • From informed consent through 30 days after last treatment 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.	29.2% 7/24 • Number of events 7 • From informed consent through 30 days after last treatment 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.	18.5% 5/27 • Number of events 5 • From informed consent through 30 days after last treatment 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.
Nervous system disorders Somnolence	8.3% 2/24 • Number of events 2 • From informed consent through 30 days after last treatment 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.	16.7% 4/24 • Number of events 4 • From informed consent through 30 days after last treatment 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.	11.1% 3/27 • Number of events 3 • From informed consent through 30 days after last treatment 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.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 • Number of events 1 • From informed consent through 30 days after last treatment 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.	16.7% 4/24 • Number of events 4 • From informed consent through 30 days after last treatment 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.	7.4% 2/27 • Number of events 2 • From informed consent through 30 days after last treatment 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.
Respiratory, thoracic and mediastinal disorders Throat Irritation	8.3% 2/24 • Number of events 2 • From informed consent through 30 days after last treatment 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.	12.5% 3/24 • Number of events 3 • From informed consent through 30 days after last treatment 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.	14.8% 4/27 • Number of events 4 • From informed consent through 30 days after last treatment 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.

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