Migraine Headache, With or Without AuraPhase 2NCT00610428
Staccato Prochlorperazine in Migraine (in Clinic)
A Phase 2 study testing Staccato Prochlorperazine 5 mg and Staccato Prochlorperazine 10 mg in people with Migraine Headache, With or Without Aura, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Development of Staccato Prochlorperazine for the treatment of migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Headache, With or Without Aura
- What is being tested?
- Staccato Prochlorperazine 5 mg and Staccato Prochlorperazine 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Oct 2005
- 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
- Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.
Who cannot join
- Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, 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 Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
Development of Staccato Prochlorperazine for the treatment of migraine headache.
- Conditions
- Migraine Headache, With or Without Aura
- Being tested
- Staccato Placebo, Staccato Prochlorperazine 5 mg, Staccato Prochlorperazine 10 mg
- Keywords
- Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.
- 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 PlaceboDrug
Inhaled Staccato Placebo
Staccato Prochlorperazine 5 mgDrug
Inhaled Prochlorperazine 5 mg
Staccato Prochlorperazine 10 mgDrug
Inhaled Prochlorperazine10 mg
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Inhaled Staccato Placebo Receives: Drug: Staccato Placebo |
| Inhaled PCZ 5 mg | Experimental | Inhaled Staccato Prochlorperazine 5 mg Receives: Drug: Staccato Prochlorperazine 5 mg |
| Inhaled PCZ 10 mg | Placebo comparator | Inhaled Staccato Prochlorperazine 10 mg Receives: Drug: Staccato Prochlorperazine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain Relief at 2 hr Post-dose by 2-point Definition
patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain
Measured: 2 hours after treatment
Secondary outcomes (1)
Survival Analysis for Time to Pain Relief
Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition
Measured: from treatment (time = 0) to 2 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMar 2005
- Primary completionOct 2005
- Study completionOct 2005
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine Headache, With or Without AuraStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Sheena Auroa, MD, Principal investigatorRoger K Cady, MD, Principal investigatorArthur Elkind, MD, Principal investigatorFred Freitag, DO, Principal investigatorLisa Mannix, MD, Principal investigatorNiana T Mathew, MD, Principal investigatorEgilius LH Spierings, MD, Principal investigatorStewart Tepper, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610428
- Sponsor's protocol ID
- AMDC-001-201
- Status last verified
- Jan 2008
- First submitted
- 28 Jan 2008
- Last updated
- 25 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Publications
Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1.
PubMed 18830225
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
- ClinicalTrials.gov ID
- NCT00610428
- Acronym / sponsor ID
- AMDC-001-201
- Conditions
- Migraine Headache, With or Without Aura
- Keywords
- Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Mar 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 25 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development of Staccato Prochlorperazine for the treatment of migraine headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Drug: Staccato PlaceboInhaled Staccato Placebo |
| Inhaled PCZ 5 mg | Experimental | Drug: Staccato Prochlorperazine 5 mgInhaled Staccato Prochlorperazine 5 mg |
| Inhaled PCZ 10 mg | Placebo comparator | Drug: Staccato Prochlorperazine 10 mgInhaled Staccato Prochlorperazine 10 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.
Key exclusion criteria (1 listed)
- Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, 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 PlaceboInhaled Staccato Placebo | Drug | Inhaled Placebo |
| Staccato Prochlorperazine 5 mgInhaled Prochlorperazine 5 mg | Drug | Inhaled PCZ 5 mg |
| Staccato Prochlorperazine 10 mgInhaled Prochlorperazine10 mg | Drug | Inhaled PCZ 10 mg |
Primary outcome
Headache Pain Relief at 2 hr Post-dose by 2-point Definition
Time frame: 2 hours after treatment
patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain
1 secondary outcome
Survival Analysis for Time to Pain Relief
Time frame: from treatment (time = 0) to 2 hours post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18830225Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1.
- Individual participant dataSharing planned: No. 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.
Sheena Auroa, MD principal investigator
Roger K Cady, MD principal investigator
Arthur Elkind, MD principal investigator
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 Prochlorperazine 5 mg and Staccato Prochlorperazine 10 mg in people with Migraine Headache, With or Without Aura, 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 1 inclusion and 1 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 25 Jan 2018. 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. 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 25 Jan 2018). 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?
Headache Pain Relief at 2 hr Post-dose by 2-point Definition (time frame: 2 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610428, which also lists 1 linked publication.
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 25 Jan 2018.