Trial Outcomes & Findings for Staccato Loxapine in Migraine (Out Patient) (NCT NCT00825500)

NCT ID: NCT00825500

Last Updated: 2017-04-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 366 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2017-04-24

Participant Flow

Participant milestones

Measure	Inhaled Placebo Inhaled Staccato Placebo (0 mg) Inhaled Placebo: Inhaled Staccato placebo (0 mg)	Inhaled Loxapine 1.25 mg Inhaled Staccato Loxapine 1.25 mg, single dose Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose	Inhaled Loxapine 2.5 mg Inhaled Staccato Loxapine 2.5 mg, single dose Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Overall Study STARTED	125	121	120
Overall Study COMPLETED	125	121	120
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Staccato Loxapine in Migraine (Out Patient)

Baseline characteristics by cohort

Measure	Inhaled Placebo n=125 Participants Inhaled Staccato Placebo (0 mg) Inhaled Placebo: Inhaled Staccato placebo (0 mg)	Inhaled Loxapine 1.25 mg n=121 Participants Inhaled Staccato Loxapine 1.25 mg, single dose Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose	Inhaled Loxapine 2.5 mg n=120 Participants Inhaled Staccato Loxapine 2.5 mg, single dose Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose	Total n=366 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=93 Participants	121 Participants n=4 Participants	120 Participants n=27 Participants	366 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	41.5 years STANDARD_DEVIATION 12.14 • n=93 Participants	41.2 years STANDARD_DEVIATION 12.19 • n=4 Participants	42 years STANDARD_DEVIATION 12.74 • n=27 Participants	41.5 years STANDARD_DEVIATION 12.33 • n=483 Participants
Sex: Female, Male Female	88 Participants n=93 Participants	100 Participants n=4 Participants	41 Participants n=27 Participants	229 Participants n=483 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	21 Participants n=4 Participants	79 Participants n=27 Participants	137 Participants n=483 Participants
Region of Enrollment United States	125 participants n=93 Participants	121 participants n=4 Participants	120 participants n=27 Participants	366 participants n=483 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: ITT with LOCF Population

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

Outcome measures

Measure	Inhaled Placebo n=124 Participants Inhaled Staccato Placebo (0 mg) Inhaled Placebo: Inhaled Staccato placebo (0 mg)	Inhaled Loxapine 1.25 mg n=121 Participants Inhaled Staccato Loxapine 1.25 mg, single dose Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose	Inhaled Loxapine 2.5 mg n=119 Participants Inhaled Staccato Loxapine 2.5 mg, single dose Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Pain-Relief at 2 Hours Post-treatment	56 Participants	65 Participants	66 Participants

SECONDARY outcome

Timeframe: 2 hours

Population: ITT with LOCF Population

Free of Photophobia at 2 Hours Post-treatment

Outcome measures

Measure	Inhaled Placebo n=124 Participants Inhaled Staccato Placebo (0 mg) Inhaled Placebo: Inhaled Staccato placebo (0 mg)	Inhaled Loxapine 1.25 mg n=121 Participants Inhaled Staccato Loxapine 1.25 mg, single dose Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose	Inhaled Loxapine 2.5 mg n=119 Participants Inhaled Staccato Loxapine 2.5 mg, single dose Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Photophobia Free	59 Participants	47 Participants	54 Participants

Adverse Events

Inhaled Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Inhaled Loxapine 1.25 mg

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Inhaled Loxapine 2.5 mg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Inhaled Placebo n=125 participants at risk Inhaled Staccato Placebo (0 mg) Inhaled Placebo: Inhaled Staccato placebo (0 mg)	Inhaled Loxapine 1.25 mg n=121 participants at risk Inhaled Staccato Loxapine 1.25 mg, single dose Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose	Inhaled Loxapine 2.5 mg n=120 participants at risk Inhaled Staccato Loxapine 2.5 mg, single dose Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose
Gastrointestinal disorders Dysgeusia	4.8% 6/125 • Number of events 6 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary	13.2% 16/121 • Number of events 16 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary	8.3% 10/120 • Number of events 10 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary
Nervous system disorders Dizziness	9.6% 12/125 • Number of events 12 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary	6.6% 8/121 • Number of events 8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary	5.0% 6/120 • Number of events 6 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary
Nervous system disorders Somnolence	3.2% 4/125 • Number of events 4 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary	2.5% 3/121 • Number of events 3 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary	6.7% 8/120 • Number of events 8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Subjects were instructed to carry out self-assessment for adverse events from dosing through 24 hours and recored in the patient diary

Additional Information

Chief Scientific Officer

Alexza Pharmaceuticals, Inc

Phone: 650.944.7777

Email: jcassella@alexza.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60