Trial · NCT00825500

Staccato Loxapine in Migraine (Out Patient)

NCT00825500, Phase 2, Completed, Alexza Pharmaceuticals, Inc.; results first posted 2017-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Staccato Loxapine in Migraine (Out Patient). Trials, record NCT00825500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00825500

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Staccato Loxapine in Migraine (Out Patient)
NCT number: NCT00825500
Status: Completed
Phases: Phase 2
Enrollment: 366 participants, actual
Lead sponsor: Alexza Pharmaceuticals, Inc.
Conditions: Migraine Headache
Interventions: Inhaled Placebo, Inhaled Loxapine 1.25 mg, Inhaled Loxapine 2.5 mg
First posted: 2009-01-21
Last updated: 2017-04-24
Results first posted: 2017-04-24

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pain-Relief at 2 Hours Post-treatment	2 hours	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
Secondary	Photophobia Free	2 hours	Free of Photophobia at 2 Hours Post-treatment

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pain-Relief at 2 Hours Post-treatment	2 hours	ITT with LOCF Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Photophobia Free	2 hours	ITT with LOCF Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Pain-Relief at 2 Hours Post-treatment	Inhaled Placebo	56	Participants
Pain-Relief at 2 Hours Post-treatment	Inhaled Loxapine 1.25 mg	65	Participants
Pain-Relief at 2 Hours Post-treatment	Inhaled Loxapine 2.5 mg	66	Participants
Photophobia Free	Inhaled Placebo	59	Participants
Photophobia Free	Inhaled Loxapine 1.25 mg	47	Participants
Photophobia Free	Inhaled Loxapine 2.5 mg	54	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Inhaled Placebo	125
Overall Study	STARTED	Inhaled Loxapine 1.25 mg	121
Overall Study	STARTED	Inhaled Loxapine 2.5 mg	120
Overall Study	COMPLETED	Inhaled Placebo	125
Overall Study	COMPLETED	Inhaled Loxapine 1.25 mg	121
Overall Study	COMPLETED	Inhaled Loxapine 2.5 mg	120
Overall Study	NOT COMPLETED	Inhaled Placebo	0
Overall Study	NOT COMPLETED	Inhaled Loxapine 1.25 mg	0
Overall Study	NOT COMPLETED	Inhaled Loxapine 2.5 mg	0

Source ClinicalTrials.gov

Adverse events9

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dysgeusia	Gastrointestinal disorders	Inhaled Placebo	6	125	6
other	Dysgeusia	Gastrointestinal disorders	Inhaled Loxapine 1.25 mg	16	121	16
other	Dysgeusia	Gastrointestinal disorders	Inhaled Loxapine 2.5 mg	10	120	10
other	Dizziness	Nervous system disorders	Inhaled Placebo	12	125	12
other	Dizziness	Nervous system disorders	Inhaled Loxapine 1.25 mg	8	121	8
other	Dizziness	Nervous system disorders	Inhaled Loxapine 2.5 mg	6	120	6
other	Somnolence	Nervous system disorders	Inhaled Placebo	4	125	4
other	Somnolence	Nervous system disorders	Inhaled Loxapine 1.25 mg	3	121	3
other	Somnolence	Nervous system disorders	Inhaled Loxapine 2.5 mg	8	120	8

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Inhaled Placebo	0	125
Total, all-cause mortality	Inhaled Loxapine 1.25 mg	0	121
Total, all-cause mortality	Inhaled Loxapine 2.5 mg	0	120
Total, other adverse events	Inhaled Placebo	22	125
Total, other adverse events	Inhaled Loxapine 1.25 mg	27	121
Total, other adverse events	Inhaled Loxapine 2.5 mg	24	120
Total, serious adverse events	Inhaled Placebo	0	125
Total, serious adverse events	Inhaled Loxapine 1.25 mg	0	121
Total, serious adverse events	Inhaled Loxapine 2.5 mg	0	120

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00825500

GET https://conductscience.org/api/trials/v1/NCT00825500/registered

API reference For AI assistants