Staccato® Prochlorperazine for Inhalation in Migraine
Information source: Alexza Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache; Aura
Intervention: Prochlorperazine thermal aerosol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Alexza Pharmaceuticals, Inc.
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. 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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome measure for this study will be patient headache pain as measured on the scale:0 = NO headache pain 1 = MILD headache pain 2 = MODERATE headache pain 3 = SEVERE headache pain
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and female patients between the ages of 18 to 70 years, inclusive.
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:
1. Patients who are currently taking tricyclic antidepressants, valproate, divalproex,
barbitals, thiazolidinediones, phenothiazines, benzodiazepines, lithium or any hepatic
toxic drugs must be excluded.
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.
Locations and Contacts
Department of Neurology, Mayo Clinic, Scottsdale, Arizona 85259, United States
California Medical Clinic for Headache, Santa Monica, California 90404, United States
Neurological Research Institute of East Bay, Walnut Creek, California 94596, United States
San Francisco Headache Clinic, San Francisco, California 94109, United States
Mile High Research Center, Denver, Colorado 80218-1110, United States
The New England Center for Headache, Stamford,, Connecticut 06902, United States
Associated Neurologists of Southern Connecticut PC, Fairfield, Connecticut 06824, United States
Hartford Headache Center, Hartford, Connecticut 06106, United States
MD Clinical, Hallandale Beach, Florida 33009, United States
Palm Beach Neurological Center, West Palm Beach, Florida 33410, United States
Diamond Headache Clinic, Chicago, Illinois 60614-1726, United States
Medvadis, Wellesley Hills, Massachusetts 02481-2106, United States
New England Regional Headache Center, Worcester, Massachusetts 01605, United States
The Michigan Head-Pain and Neurological Institute, Ann Arbor, Michigan 48104.5199, United States
Headache Care Center Primary Care Network, INC, Springfield, Missouri 65807, United States
Elkind Headache Center, Mt. Vernon, New York 10050, United States
Island Neurological Associates, PC, Plainview, New York 11803, United States
New York Headache Center, New York, New York 10021, United States
Regional Clinical Research, Endwell, New York 13760, United States
PharmQuest, Greensboro, North Carolina 27401, United States
ClinExcel Research, West Chester, Ohio 45069, United States
Health Research Associates, Cleveland, Ohio 44121, United States
University Neurologists/OUHSC, Oklahoma City, Oklahoma 73104, United States
Houston Headache Clinic, Houston, Texas 77004, United States
Swedish Research Center, Seattle, Washington 98104, United States
Additional Information
Starting date: April 2006
Last updated: June 2, 2008
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