Staccato Loxapine in Migraine (Out Patient)

NCT00825500 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: AMDC-104-20224-October-2008
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Migraine Headache

Keywords

Migraine headache; Loxapine; Staccato

Outcome Measures

Primary Outcomes (1)

• Pain-Relief at 2 Hours Post-treatment

  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

  2 hours

Secondary Outcomes (1)

• Photophobia Free

  2 hours

Study Arms (3)

Inhaled Placebo

PLACEBO COMPARATOR

Inhaled Staccato Placebo (0 mg)

Drug: Inhaled Placebo

Inhaled Loxapine 1.25 mg

ACTIVE COMPARATOR

Inhaled Staccato Loxapine 1.25 mg, single dose

Drug: Inhaled Loxapine 1.25 mg

Inhaled Loxapine 2.5 mg

EXPERIMENTAL

Inhaled Staccato Loxapine 2.5 mg, single dose

Drug: Inhaled Loxapine 2.5 mg

Interventions

Inhaled Placebo DRUG

Inhaled Staccato placebo (0 mg)

Inhaled Placebo

Inhaled Loxapine 1.25 mg DRUG

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg

Inhaled Loxapine 2.5 mg DRUG

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 2.5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agreed to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception that could be used by the participant and/or his/her partner included abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and progestin implant or injection. Prohibited methods included the rhythm method, withdrawal, condoms alone, or diaphragm alone.

You may not qualify if:

• 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
• Receipt of an investigational drug within 30 days prior to the screening visit
• Considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (3)

Roger K. Cady

Springfield, Missouri, 65807, United States

Location

Elkind Headache Center

Mount Vernon, New York, 10550, United States

Location

CNS Research, Inc.

East Providence, Rhode Island, 02916, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Alexza Pharmaceuticals, Inc

jcassella@alexza.com

650.944.7777

Study Officials

• Roger K. Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

• Peter J. Bellafiore, MD

  CNS Research, Inc.

  PRINCIPAL INVESTIGATOR

• Arthur Elkind, MD

  Elkind Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 24, 2017
• Results First Posted: April 24, 2017

Record last verified: 2009-08

Data Sharing

• IPD Sharing: Will share

Locations

US (3)