Loading clinical trials...

Staccato Loxapine in Migraine (Out Patient) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Staccato Loxapine in Migraine (Out Patient)

A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache

NCT00825500•Alexza Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Detailed Description

This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female between the ages of 18 to 65 years, inclusive
•History of migraine headache with or without aura (according to IHS Criteria 1.1 or 1.2 for diagnosis beginning at least 6 months prior to study entry) (International Headache Society Clinical Trials Subcommittee, 2000)
•At least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks in the last month)
•Pain rating of moderate or severe (on a none-mild- moderate-severe scale) prior to dosing
•Agreed not to use the study drug within 72 hours of a prior migraine attack
•Agreed not to use any acute migraine or pain medication within 48 hours prior to dosing (including over-the-counter \[OTC\] products); medications for migraine prophylaxis other than those that were exclusionary were permitted if stable doses had been given for at least 30 days prior to screening
•Agreed not to use medications (including OTC products) for motion sickness, tinnitus, or vertigo within 48 hours prior to dosing.
•Were able to speak, read, and understand English and were willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures
•Were willing and able to comply with the study schedule and requirements, and agreed to return to the clinic within 5 working days of use of the study drug
•In good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead electrocardiogram (ECG), blood chemistry profile, hematology, urinalysis, and in the opinion of the investigator
+1 more criteria

Exclusion Criteria

•Use of antipsychotics (including butryophenones, phenothiazines, thioxanthenes, aripiprazle, olanzapine, risperidone), tricyclic antidepressants, trazodone, anticonvulsants (except topiramate), barbiturates, benzodiazepines, or lithium within 14 days or 5 half-lives, whichever was longer, of randomization and at anytime throughout the study
•History of contraindications to anticholinergic agents (eg, bowel or urinary obstruction, stenosing peptic ulcers, narrow-angle glaucoma)
•History of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine)
•History of extrapyramidal disorders, movement disorders including Parkinson's disease or neuroleptic malignant syndrome
•Female patients with a positive pregnancy test at screening or during randomization visit, or who were breastfeeding
•History within the past year of drug or alcohol dependence or abuse as defined by DSM IV
•History of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, or uncontrolled hypertension
•History of a major neurological disorder other than migraine (seizure disorder, subarachnoid bleeding, stroke, brain tumor, or transient ischemic attack)
•Any other disease(s), by history, physical examination, or laboratory abnormalities (including alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 2-fold the upper limit of normal, total bilirubin \> 1.5 mg/dL, or creatinine \> 1.8 mg/dL), that in the investigator's opinion, would present undue risk to the patient or could confound the interpretation of study results
•History of asthma or chronic obstructive lung disease or any use of an inhaler prescribed for wheezing or bronchospasm in the past 5 years
+2 more criteria

Locations (3)

Roger K. Cady

Springfield, Missouri, United States

Elkind Headache Center

Mount Vernon, New York, United States

CNS Research, Inc.

East Providence, Rhode Island, United States

Key Dates

Start Date

January 1, 2009

Primary Completion Date

August 1, 2009

Completion Date

August 1, 2009

Last Updated

April 24, 2017

Enrollment

366

ACTUAL participants

Conditions

Migraine Headache

Interventions

Inhaled Placebo

DRUG

Inhaled Loxapine 1.25 mg

DRUG

Inhaled Loxapine 2.5 mg

DRUG

Light Exposure, Migraine Outcomes, and Sleep Quality

NCT07476053

Migraine HeadacheSleep+1 more

View study

RECRUITINGNA

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

NCT06203873

PFO - Patent Foramen OvaleMigraine+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Staccato Loxapine in Migraine (Out Patient)

Inclusion Criteria

Exclusion Criteria

Light Exposure, Migraine Outcomes, and Sleep Quality

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Vitamin K2 Supplementation in Adult Episodic Migraine

Neurostimulation Device for Treatment of Migraine Headache

Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

Efficacy, Tolerability, and Safety of DFN-15