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Staccato® Prochlorperazine for Inhalation in Migraine
This study has been completed.
First Received: January 12, 2007   Last Updated: June 2, 2008   History of Changes
Sponsor: Alexza Pharmaceuticals, Inc.
Information provided by: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00422812
  Purpose

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.


Condition Intervention Phase
Migraine Headache
Aura
Drug: Prochlorperazine thermal aerosol
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422812

  Hide Study Locations
Locations
United States, Arizona
Department of Neurology, Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
Neurological Research Institute of East Bay
Walnut Creek, California, United States, 94596
San Francisco Headache Clinic
San Francisco, California, United States, 94109
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218-1110
United States, Connecticut
The New England Center for Headache
Stamford,, Connecticut, United States, 06902
Associated Neurologists of Southern Connecticut PC
Fairfield, Connecticut, United States, 06824
Hartford Headache Center
Hartford, Connecticut, United States, 06106
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Palm Beach Neurological Center
West Palm Beach, Florida, United States, 33410
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614-1726
United States, Massachusetts
Medvadis
Wellesley Hills, Massachusetts, United States, 02481-2106
New England Regional Headache Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
The Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States, 48104.5199
United States, Missouri
Headache Care Center Primary Care Network, INC
Springfield, Missouri, United States, 65807
United States, New York
Elkind Headache Center
Mt. Vernon, New York, United States, 10050
Regional Clinical Research
Endwell, New York, United States, 13760
New York Headache Center
New York, New York, United States, 10021
Island Neurological Associates, PC
Plainview, New York, United States, 11803
United States, North Carolina
PharmQuest
Greensboro, North Carolina, United States, 27401
United States, Ohio
ClinExcel Research
West Chester, Ohio, United States, 45069
Health Research Associates
Cleveland, Ohio, United States, 44121
United States, Oklahoma
University Neurologists/OUHSC
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Houston Headache Clinic
Houston, Texas, United States, 77004
United States, Washington
Swedish Research Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Alexza Pharmaceuticals, Inc. ( Dan Spyker )
Study ID Numbers: AMDC-001-202
Study First Received: January 12, 2007
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00422812     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Migraine, Staccato Prochlorperazine
Migraine headache with or without aura.

Additional relevant MeSH terms:
Prochlorperazine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders
Signs and Symptoms
Migraine Disorders
Therapeutic Uses
Headache
Tranquilizing Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Autonomic Agents
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009