MigrainePhase 2NCT00489476
Staccato Loxapine in Migraine (in Clinic)
A Phase 2 study testing Staccato Loxapine in people with Migraine, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Staccato Loxapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients between the ages of 18 to 65 years, inclusive.
- Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months.
- Patients who have a history of migraine and have had at least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks in the last month).
- Patients who have been pain free for at least 48 hours since the end of their last migraine attack.
- Patients who have not taken any acute migraine or pain medication within 48 hours prior to dosing (including OTC products).
- Patients who have a pain rating of Moderate or Severe (on a None-Mild- Moderate-Severe Scale) prior to dosing.
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- Patients who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
- Patients who are willing and able to comply with the study schedule and requirements, are willing and able to travel to the Clinical Research Unit (CRU) for treatment and stay at the CRU for approximately a 4-6 hour period, and agree to return to the clinic within 5 working days of use of the investigational treatment.
- Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal 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 agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include 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 include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
Who cannot join
- Patients who are currently taking antipsychotics, tricyclic antidepressants, valproate, barbiturates, benzodiazepines, or lithium must be excluded.
- Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded.
- Patients with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
- Patients with a history of extra-pyramidal disorders, movement disorders including Parkinson's disease, and patients with a history of neuroleptic malignant syndrome must be excluded.
- Female patients who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
- Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
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- Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded.
- Patients who have a history of a major neurological disorder other than migraine (seizure disorder, subarachnoid bleeding, stroke, brain tumor) must be excluded.
- Patients who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, Bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion, would present undue risk to the patient or may confound the interpretation of study results must be excluded.
- Patients who have a history of asthma or chronic obstructive lung disease should be excluded.
- Patients who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
- Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.
Trial locations and contacts
1 site in 1 country.
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 Patients With Migraine Headache
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
Read the detailed description
This study will enroll male and female patients with migraine headache with or without aura. The study will randomize ~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.
- Conditions
- Migraine
- Being tested
- Staccato Loxapine, Staccato Placebo
- Keywords
- Staccato® Loxapine, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staccato LoxapineDrug
Also called ADASUVE
Staccato PlaceboDrug
Placebo aerosol inhalation (0mg)
| Study group | Role | What they receive |
|---|---|---|
| 1.25 mg Staccato Loxapine | Experimental | 1.25 mg ADASUVE, single dose Receives: Drug: Staccato Loxapine |
| 2.5 mg Staccato Loxapine | Experimental | 2.5 mg ADASUVE, single dose Receives: Drug: Staccato Loxapine |
| 5 mg Staccato Loxapine | Experimental | 5 mg ADASUVE, single dose Receives: Drug: Staccato Loxapine |
| Staccato Placebo | Experimental | Staccato Placebo, 0 mg Receives: Drug: Staccato Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours
The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD.
Intent to treat (ITT) with last observation carried forward (LOCF)
Measured: Baseline and 2 h post-dose
Secondary outcomes (1)
Pain-free at 2 Hours
Pain-free (Pain-IHS) at the 2 hour time point
Measured: Baseline and 2 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
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 MigraineStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Egilius Spierings, MD, Principal investigator, MedVadis Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489476
- Sponsor's protocol ID
- AMDC-104-201
- Status last verified
- Apr 2008
- First submitted
- 20 Jun 2007
- Last updated
- 6 Jul 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 6 Jul 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 Patients With Migraine Headache
- ClinicalTrials.gov ID
- NCT00489476
- Acronym / sponsor ID
- AMDC-104-201
- Conditions
- Migraine
- Keywords
- Staccato® Loxapine, Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Jun 2007 (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.
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
Detailed description
This study will enroll male and female patients with migraine headache with or without aura. The study will randomize ~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.25 mg Staccato Loxapine | Experimental | Drug: Staccato Loxapine1.25 mg ADASUVE, single dose |
| 2.5 mg Staccato Loxapine | Experimental | Drug: Staccato Loxapine2.5 mg ADASUVE, single dose |
| 5 mg Staccato Loxapine | Experimental | Drug: Staccato Loxapine5 mg ADASUVE, single dose |
| Staccato Placebo | Experimental | Drug: Staccato PlaceboStaccato Placebo, 0 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients between the ages of 18 to 65 years, inclusive.
- Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months.
- Patients who have a history of migraine and have had at least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks in the last month).
- Patients who have been pain free for at least 48 hours since the end of their last migraine attack.
- Patients who have not taken any acute migraine or pain medication within 48 hours prior to dosing (including OTC products).
Key exclusion criteria (12 listed)
- Patients who are currently taking antipsychotics, tricyclic antidepressants, valproate, barbiturates, benzodiazepines, or lithium must be excluded.
- Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded.
- Patients with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
- Patients with a history of extra-pyramidal disorders, movement disorders including Parkinson's disease, and patients with a history of neuroleptic malignant syndrome must be excluded.
- Female patients who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
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 |
|---|---|---|
| Staccato LoxapineAlso: ADASUVE | Drug | 1.25 mg Staccato Loxapine, 2.5 mg Staccato Loxapine, 5 mg Staccato Loxapine |
| Staccato PlaceboPlacebo aerosol inhalation (0mg) | Drug | Staccato Placebo |
Primary outcome
Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours
Time frame: Baseline and 2 h post-dose
The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD. Intent to treat (ITT) with last observation carried forward (LOCF)
1 secondary outcome
Pain-free at 2 Hours
Time frame: Baseline and 2 h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
Egilius Spierings, MD principal investigator
MedVadis Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Staccato Loxapine in people with Migraine, run by Alexza Pharmaceuticals, Inc. at 1 site 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 10 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Response (Pain Severity of NONE or MILD) at 2 Hours (time frame: Baseline and 2 h post-dose). 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 6 Jul 2017.