Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
400 participants
INTERVENTIONAL
2006-04-30
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inhaled Placebo
Inhaled Staccato Placebo
Inhaled Placebo
Inhaled Staccato Placebo
Inhaled PCZ 5 mg
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 5 mg
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 7.5 mg
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 7.5 mg
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 10 mg
Inhaled Staccato Prochlorperazine 10 mg
Inhaled PCZ 10 mg
Inhaled Staccato Prochlorperazine 10 mg
Interventions
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Inhaled Placebo
Inhaled Staccato Placebo
Inhaled PCZ 5 mg
Inhaled Staccato Prochlorperazine 5 mg
Inhaled PCZ 7.5 mg
Inhaled Staccato Prochlorperazine 7.5 mg
Inhaled PCZ 10 mg
Inhaled Staccato Prochlorperazine 10 mg
Eligibility Criteria
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Inclusion Criteria
2. Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
Exclusion Criteria
2. Patients who are currently taking medications that prolong the QT/QTc interval (see Appendix 4) must be excluded.
3. Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded.
4. Patients with a history of allergy or intolerance to phenothiazines and related drugs (prochlorperazine, chlorpromazine, promethazine, mesoridazine, thioridazine, fluphenazine, perphenazine) must be excluded.
5. Patients with a history of extra-pyramidal disorders, movement disorders, neuroleptic malignant syndrome, or major affective disorder must be excluded.
6. Female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
7. Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
8. Patients who have a history of pheochromocytoma, seizure disorder or Parkinson's disease must be excluded.
9. Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 mos), congestive heart failure, or transient ischemic attack must be excluded.
10. Patients who have a history of a major neurological disorder other than migraine (subarachnoidal bleeding, stroke, brain tumor) must be excluded.
11. 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.
12. Patients who have a history of asthma or chronic obstructive lung disease should be excluded.
13. Patients who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
14. 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.
15. 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.
16. 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.
18 Years
70 Years
ALL
No
Sponsors
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Alexza Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel A Spyker, PhD, MD
Role: STUDY_DIRECTOR
Alexza Pharmaceuticals, Inc.
Locations
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Department of Neurology, Mayo Clinic
Scottsdale, Arizona, United States
San Francisco Headache Clinic
San Francisco, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Neurological Research Institute of East Bay
Walnut Creek, California, United States
Mile High Research Center
Denver, Colorado, United States
Associated Neurologists of Southern Connecticut PC
Fairfield, Connecticut, United States
Hartford Headache Center
Hartford, Connecticut, United States
The New England Center for Headache
Stamford, Connecticut, United States
MD Clinical
Hallandale, Florida, United States
Palm Beach Neurological Center
West Palm Beach, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Medvadis
Wellesley Hills, Massachusetts, United States
New England Regional Headache Center
Worcester, Massachusetts, United States
The Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States
Headache Care Center Primary Care Network, INC
Springfield, Missouri, United States
Regional Clinical Research
Endwell, New York, United States
Elkind Headache Center
Mount Vernon, New York, United States
New York Headache Center
New York, New York, United States
Island Neurological Associates, PC
Plainview, New York, United States
PharmQuest
Greensboro, North Carolina, United States
Health Research Associates
Cleveland, Ohio, United States
ClinExcel Research
West Chester, Ohio, United States
University Neurologists/OUHSC
Oklahoma City, Oklahoma, United States
Houston Headache Clinic
Houston, Texas, United States
Swedish Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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AMDC-001-202
Identifier Type: -
Identifier Source: org_study_id
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