Migraine HeadachePhase 2NCT00825500
Staccato Loxapine in Migraine (Out Patient)
A Phase 2 study testing Inhaled Loxapine 1.25 mg and Inhaled Loxapine 2.5 mg in people with Migraine Headache, run by Alexza Pharmaceuticals, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Inhaled Loxapine 1.25 mg and Inhaled Loxapine 2.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CNS Research, Inc.
East Providence, Rhode Island, 02916
Elkind Headache Center
Mount Vernon, New York, 10550
Roger K. Cady
Springfield, Missouri, 65807
About this study
Official title: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Inhaled Placebo, Inhaled Loxapine 1.25 mg, Inhaled Loxapine 2.5 mg
- Keywords
- Migraine headache, Loxapine, Staccato
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled PlaceboDrug
Inhaled Staccato placebo (0 mg)
Inhaled Loxapine 1.25 mgDrug
Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 2.5 mgDrug
Inhaled Staccato Loxapine 1.25 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Inhaled Staccato Placebo (0 mg) Receives: Drug: Inhaled Placebo |
| Inhaled Loxapine 1.25 mg | Active comparator | Inhaled Staccato Loxapine 1.25 mg, single dose Receives: Drug: Inhaled Loxapine 1.25 mg |
| Inhaled Loxapine 2.5 mg | Experimental | Inhaled Staccato Loxapine 2.5 mg, single dose Receives: Drug: Inhaled Loxapine 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (1)
Photophobia Free
Free of Photophobia at 2 Hours Post-treatment
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Roger K. Cady, MD, Principal investigator, ClinvestPeter J. Bellafiore, MD, Principal investigator, CNS Research, Inc.Arthur Elkind, MD, Principal investigator, Elkind Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825500
- Sponsor's protocol ID
- AMDC-104-202
- Other IDs
- 24-October-2008
- Status last verified
- Aug 2009
- First submitted
- 19 Jan 2009
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache
- ClinicalTrials.gov ID
- NCT00825500
- Acronym / sponsor ID
- AMDC-104-202
- Conditions
- Migraine Headache
- Keywords
- Migraine headache, Loxapine, Staccato
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Drug: Inhaled PlaceboInhaled Staccato Placebo (0 mg) |
| Inhaled Loxapine 1.25 mg | Active comparator | Drug: Inhaled Loxapine 1.25 mgInhaled Staccato Loxapine 1.25 mg, single dose |
| Inhaled Loxapine 2.5 mg | Experimental | Drug: Inhaled Loxapine 2.5 mgInhaled Staccato Loxapine 2.5 mg, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled PlaceboInhaled Staccato placebo (0 mg) | Drug | Inhaled Placebo |
| Inhaled Loxapine 1.25 mgInhaled Staccato Loxapine 1.25 mg, single dose | Drug | Inhaled Loxapine 1.25 mg |
| Inhaled Loxapine 2.5 mgInhaled Staccato Loxapine 1.25 mg, single dose | Drug | Inhaled Loxapine 2.5 mg |
Primary outcome
Pain-Relief at 2 Hours Post-treatment
Time frame: 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
1 secondary outcome
Photophobia Free
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger K. Cady, MD principal investigator
Clinvest
Peter J. Bellafiore, MD principal investigator
CNS Research, Inc.
Arthur Elkind, MD principal investigator
Elkind Headache Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Loxapine 1.25 mg and Inhaled Loxapine 2.5 mg in people with Migraine Headache, run by Alexza Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-Relief at 2 Hours Post-treatment (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.