Migraine HeadachePhase 2NCT00422812
Staccato Prochlorperazine in Migraine (Out Patient)
A Phase 2 study testing Inhaled PCZ 5 mg, Inhaled PCZ 7.5 mg and Inhaled PCZ 10 mg in people with Migraine Headache and Aura, run by Alexza Pharmaceuticals, Inc. at 25 sites in United States.
Trial summary
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine Headache, Aura
- What is being tested?
- Inhaled PCZ 5 mg, Inhaled PCZ 7.5 mg and Inhaled PCZ 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 25 sitesUnited States
- Study dates
- Apr 2006to Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between the ages of 18 to 70 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 per month). Current and past migraine medication history must be recorded.
- Patients who agree to: not use the study drug within 72 hr of a prior migraine attack, and to use the investigational medication when they have a pain rating of Moderate or Severe (on a None, Mild, Moderate or Severe Scale) prior to dosing.
- Patients who speak, read, and understand English sufficiently well 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 comply with the study schedule and study requirements, 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 tricyclic antidepressants, valproate, divalproex, barbitals, thiazolidinediones, phenothiazines, benzodiazepines, lithium or any hepatic toxic drugs must be excluded.
- Patients who are currently taking medications that prolong the QT/QTc interval (see Appendix 4) 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 phenothiazines and related drugs (prochlorperazine, chlorpromazine, promethazine, mesoridazine, thioridazine, fluphenazine, perphenazine) must be excluded.
- Patients with a history of extra-pyramidal disorders, movement disorders, neuroleptic malignant syndrome, or major affective disorder must be excluded.
- Female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
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- Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
- Patients who have a history of pheochromocytoma, seizure disorder or Parkinson's disease must be excluded.
- Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 mos), congestive heart failure, or transient ischemic attack must be excluded.
- Patients who have a history of a major neurological disorder other than migraine (subarachnoidal 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 have a history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) must be excluded.
- Patients who have a marked prolongation of QT/QTc interval (e.g., demonstration of a QT interval >450 ms on screening ECG) must be excluded.
- Patients who 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
25 sites in 1 country.
25 sites in 1 country
United States25 sites
The Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, 48104.5199
Diamond Headache Clinic
Chicago, Illinois, 60614-1726
Health Research Associates
Cleveland, Ohio, 44121
Mile High Research Center
Denver, Colorado, 80218-1110
Regional Clinical Research
Endwell, New York, 13760
Associated Neurologists of Southern Connecticut PC
Fairfield, Connecticut, 06824
PharmQuest
Greensboro, North Carolina, 27401
MD Clinical
Hallandale, Florida, 33009
Hartford Headache Center
Hartford, Connecticut, 06106
Houston Headache Clinic
Houston, Texas, 77004
Elkind Headache Center
Mount Vernon, New York, 10050
New York Headache Center
New York, New York, 10021
University Neurologists/OUHSC
Oklahoma City, Oklahoma, 73104
Island Neurological Associates, PC
Plainview, New York, 11803
San Francisco Headache Clinic
San Francisco, California, 94109
California Medical Clinic for Headache
Santa Monica, California, 90404
Department of Neurology, Mayo Clinic
Scottsdale, Arizona, 85259
Swedish Research Center
Seattle, Washington, 98104
Headache Care Center Primary Care Network, INC
Springfield, Missouri, 65807
The New England Center for Headache
Stamford, Connecticut, 06902
Neurological Research Institute of East Bay
Walnut Creek, California, 94596
Medvadis
Wellesley Hills, Massachusetts, 02481-2106
ClinExcel Research
West Chester, Ohio, 45069
Palm Beach Neurological Center
West Palm Beach, Florida, 33410
New England Regional Headache Center
Worcester, Massachusetts, 01605
About this study
Official title: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose, Efficacy and Safety Outpatient Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.
- Conditions
- Migraine Headache, Aura
- Being tested
- Inhaled Placebo, Inhaled PCZ 5 mg, Inhaled PCZ 7.5 mg, Inhaled PCZ 10 mg
- Keywords
- Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.
- Medical subject headings
- Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled PlaceboDrug
Inhaled Staccato Placebo
Inhaled PCZ 5 mgDrug
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 7.5 mgDrug
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 10 mgDrug
Inhaled Staccato Prochlorperazine 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Inhaled Staccato Placebo Receives: Drug: Inhaled Placebo |
| Inhaled PCZ 5 mg | Experimental | Inhaled Staccato Prochlorperazine 5 mg Receives: Drug: Inhaled PCZ 5 mg |
| Inhaled PCZ 7.5 mg | Experimental | Inhaled Staccato Prochlorperazine 7.5 mg Receives: Drug: Inhaled PCZ 7.5 mg |
| Inhaled PCZ 10 mg | Experimental | Inhaled Staccato Prochlorperazine 10 mg Receives: Drug: Inhaled PCZ 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
Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),
Measured: 2 hr post-dose
Secondary outcomes (2)
Responders, Pain-Free at 2 Hours
Percentage of Responders, Pain-Free, by Treatment Group over Time
Measured: 2 hours
Survival of Headache Pain Relief
Survival for time to the first successful headache pain relief by Pain-IHS definition over the 0 to 4 hr period by treatment assigned. Pairwise comparisons were made for each of the 3 active doses to placebo. Survival Analysis (Kaplan-Meyer) was included to evaluate treatment efficacy over the 0 to 4 hr period. All tests were 2-sided with a p-value at α=0.05.
Measured: 0 to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionJan 2007
- Study completionJan 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel A Spyker, PhD, MD, Study director, Alexza Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422812
- Sponsor's protocol ID
- AMDC-001-202
- Status last verified
- Jun 2008
- First submitted
- 12 Jan 2007
- 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
- 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 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, Single Dose, Efficacy and Safety Outpatient Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
- ClinicalTrials.gov ID
- NCT00422812
- Acronym / sponsor ID
- AMDC-001-202
- Conditions
- Migraine Headache, Aura
- Keywords
- Migraine, Staccato Prochlorperazine, Migraine headache with or without aura.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Apr 2006 (actual)
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 17 Jan 2007 (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.
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.
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 |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Drug: Inhaled PlaceboInhaled Staccato Placebo |
| Inhaled PCZ 5 mg | Experimental | Drug: Inhaled PCZ 5 mgInhaled Staccato Prochlorperazine 5 mg |
| Inhaled PCZ 7.5 mg | Experimental | Drug: Inhaled PCZ 7.5 mgInhaled Staccato Prochlorperazine 7.5 mg |
| Inhaled PCZ 10 mg | Experimental | Drug: Inhaled PCZ 10 mgInhaled Staccato Prochlorperazine 10 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients between the ages of 18 to 70 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 per month). Current and past migraine medication history must be recorded.
- Patients who agree to: not use the study drug within 72 hr of a prior migraine attack, and to use the investigational medication when they have a pain rating of Moderate or Severe (on a None, Mild, Moderate or Severe Scale) prior to dosing.
- Patients who speak, read, and understand English sufficiently well and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
Key exclusion criteria (16 listed)
- Patients who are currently taking tricyclic antidepressants, valproate, divalproex, barbitals, thiazolidinediones, phenothiazines, benzodiazepines, lithium or any hepatic toxic drugs must be excluded.
- Patients who are currently taking medications that prolong the QT/QTc interval (see Appendix 4) 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 phenothiazines and related drugs (prochlorperazine, chlorpromazine, promethazine, mesoridazine, thioridazine, fluphenazine, perphenazine) must be excluded.
- Patients with a history of extra-pyramidal disorders, movement disorders, neuroleptic malignant syndrome, or major affective disorder 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 |
|---|---|---|
| Inhaled PlaceboInhaled Staccato Placebo | Drug | Inhaled Placebo |
| Inhaled PCZ 5 mgInhaled Staccato Prochlorperazine 5 mg | Drug | Inhaled PCZ 5 mg |
| Inhaled PCZ 7.5 mgInhaled Staccato Prochlorperazine 7.5 mg | Drug | Inhaled PCZ 7.5 mg |
| Inhaled PCZ 10 mgInhaled Staccato Prochlorperazine 10 mg | Drug | Inhaled PCZ 10 mg |
Primary outcome
Headache Pain Relief at 2 hr
Time frame: 2 hr post-dose
Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),
2 secondary outcomes
Responders, Pain-Free at 2 Hours
Time frame: 2 hours
Survival of Headache Pain Relief
Time frame: 0 to 4 hours
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.
- 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.
Daniel A Spyker, PhD, MD study director
Alexza Pharmaceuticals, Inc.
25 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 PCZ 5 mg, Inhaled PCZ 7.5 mg and Inhaled PCZ 10 mg in people with Migraine Headache and Aura, run by Alexza Pharmaceuticals, Inc. at 25 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 8 inclusion and 16 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 25 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 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 (time frame: 2 hr 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 25 Jan 2018.