MigrainePhase 1NCT00610727
Staccato Prochlorperazine Single Dose PK Study
A Phase 1 study testing Prochlorperazine 0.5 mg IV over 5 sec, Inhaled prochlorperazine 0.625 mg and Inhaled prochlorperazine 1.25 mg in people with Migraine, run by Nova Pneuma Inc. at 1 site in United States.
Trial summary
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Prochlorperazine 0.5 mg IV over 5 sec, Inhaled prochlorperazine 0.625 mg and Inhaled prochlorperazine 1.25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Oct 2004
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
Who cannot join
- Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
Read the detailed description
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.
- Conditions
- Migraine
- Being tested
- Prochlorperazine 0.5 mg IV over 5 sec, Inhaled prochlorperazine 0.625 mg, Inhaled prochlorperazine 1.25 mg, Inhaled prochlorperazine 2.5 mg, Inhaled prochlorperazine 5 mg
- Keywords
- Migraine, Prochlorperazine aerosol
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prochlorperazine 0.5 mg IV over 5 secDrug
Also called PCZ
IV Prochlorperazine for bioavailability
Inhaled prochlorperazine 0.625 mgDrug
Also called PCZ
Inhaled Staccato Prochlorperazine 0.625 mg
Inhaled prochlorperazine 1.25 mgDrug
Also called PCZ
Inhaled Staccato Prochlorperazine 1.25 mg
Inhaled prochlorperazine 2.5 mgDrug
Also called PCZ
Inhaled Staccato Prochlorperazine 2.5 mg
Inhaled prochlorperazine 5 mgDrug
Also called PCZ
InhaledStaccato Prochlorperazine 5 mg
Inhaled prochlorperazine 10 mgDrug
Also called PCZ
InhaledStaccato Prochlorperazine 10 mg
Inhaled placeboDrug
Also called ADASUVE placebo
Inhaled Staccato Placebo (0 mg)
Prochlorperazine 10 mg IV over 5 secDrug
Also called PCZ
Prochlorperazine 10 mg IV over 5 sec for patient qualification
| Study group | Role | What they receive |
|---|---|---|
| Inhaled prochlorperazine 0.625 mg vs IV | Experimental | Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg Receives: Drug: Prochlorperazine 0.5 mg IV over 5 sec; Drug: Inhaled prochlorperazine 0.625 mg; Drug: Prochlorperazine 10 mg IV over 5 sec |
| Inhaled prochlorperazine 1.25 mg | Experimental | Inhaled Staccato prochlorperazine 1.25 mg Receives: Drug: Inhaled prochlorperazine 1.25 mg |
| Inhaled prochlorperazine 2.5 mg | Experimental | Inhaled Staccato prochlorperazine 2.5 mg Receives: Drug: Inhaled prochlorperazine 2.5 mg |
| Inhaled prochlorperazine 5 mg | Experimental | Inhaled Staccato prochlorperazine 5 mg Receives: Drug: Inhaled prochlorperazine 5 mg |
| Inhaled prochlorperazine 10 mg | Experimental | Inhaled Staccato prochlorperazine 10 mg Receives: Drug: Inhaled prochlorperazine 10 mg |
| inhaled Placebo | Placebo comparator | inhaled Staccato Placebo (0 mg) Receives: Drug: Inhaled placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Peak (Tmax)
Time from dose to peak prochlorperazine concentration
Measured: 24 hours
Secondary outcomes (2)
Absolute Bioavailability of Inhaled Prochlorperazine
Absolute bioavailability of inhaled prochlorperazine via AUC infinity
Measured: 24 hours
Dose Proportionality of Inhaled Prochlorperazine by Power Analysis
Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being "perfect". Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is "as good as it gets".
Measured: 24 hours
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 startAug 2004
- Primary completionOct 2004
- Study completionOct 2004
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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Pneuma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Daniel A Spyker, MD, Study director, Alexza Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610727
- Sponsor's protocol ID
- AMDC-004-001
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2008
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00610727
- Acronym / sponsor ID
- AMDC-004-001
- Conditions
- Migraine
- Keywords
- Migraine, Prochlorperazine aerosol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Nova Pneuma Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Aug 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 5 Nov 2018
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 study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
Detailed description
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
| Arm | Type | Receives |
|---|---|---|
| Inhaled prochlorperazine 0.625 mg vs IV | Experimental | Drug: Prochlorperazine 0.5 mg IV over 5 sec, Drug: Inhaled prochlorperazine 0.625 mg, Drug: Prochlorperazine 10 mg IV over 5 secProchlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg |
| Inhaled prochlorperazine 1.25 mg | Experimental | Drug: Inhaled prochlorperazine 1.25 mgInhaled Staccato prochlorperazine 1.25 mg |
| Inhaled prochlorperazine 2.5 mg | Experimental | Drug: Inhaled prochlorperazine 2.5 mgInhaled Staccato prochlorperazine 2.5 mg |
| Inhaled prochlorperazine 5 mg | Experimental | Drug: Inhaled prochlorperazine 5 mgInhaled Staccato prochlorperazine 5 mg |
| Inhaled prochlorperazine 10 mg | Experimental | Drug: Inhaled prochlorperazine 10 mgInhaled Staccato prochlorperazine 10 mg |
| inhaled Placebo | Placebo comparator | Drug: Inhaled placeboinhaled Staccato Placebo (0 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
Key exclusion criteria (1 listed)
- Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
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 |
|---|---|---|
| Prochlorperazine 0.5 mg IV over 5 secAlso: PCZIV Prochlorperazine for bioavailability | Drug | Inhaled prochlorperazine 0.625 mg vs IV |
| Inhaled prochlorperazine 0.625 mgAlso: PCZInhaled Staccato Prochlorperazine 0.625 mg | Drug | Inhaled prochlorperazine 0.625 mg vs IV |
| Inhaled prochlorperazine 1.25 mgAlso: PCZInhaled Staccato Prochlorperazine 1.25 mg | Drug | Inhaled prochlorperazine 1.25 mg |
| Inhaled prochlorperazine 2.5 mgAlso: PCZInhaled Staccato Prochlorperazine 2.5 mg | Drug | Inhaled prochlorperazine 2.5 mg |
| Inhaled prochlorperazine 5 mgAlso: PCZInhaledStaccato Prochlorperazine 5 mg | Drug | Inhaled prochlorperazine 5 mg |
| Inhaled prochlorperazine 10 mgAlso: PCZInhaledStaccato Prochlorperazine 10 mg | Drug | Inhaled prochlorperazine 10 mg |
| Inhaled placeboAlso: ADASUVE placeboInhaled Staccato Placebo (0 mg) | Drug | inhaled Placebo |
| Prochlorperazine 10 mg IV over 5 secAlso: PCZProchlorperazine 10 mg IV over 5 sec for patient qualification | Drug | Inhaled prochlorperazine 0.625 mg vs IV |
Primary outcome
Time to Peak (Tmax)
Time frame: 24 hours
Time from dose to peak prochlorperazine concentration
2 secondary outcomes
Absolute Bioavailability of Inhaled Prochlorperazine
Time frame: 24 hours
Dose Proportionality of Inhaled Prochlorperazine by Power Analysis
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- 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
Related trials for Migraine
Recruiting
Basic Body Awareness Therapy in Individuals With Migraine
Migraine
Recruiting
Cocoa Extract for Migraine Trial
Migraine
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Acute Treatment of Migraine
RecruitingPhase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
Migraine, Migraine Disease
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
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.
Daniel A Spyker, MD study director
Alexza Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prochlorperazine 0.5 mg IV over 5 sec, Inhaled prochlorperazine 0.625 mg and Inhaled prochlorperazine 1.25 mg in people with Migraine, run by Nova Pneuma 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 22 Apr 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Nov 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?
Time to Peak (Tmax) (time frame: 24 hours). 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 NCT00610727, 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 22 Apr 2026.