Clinical trial NCT00422812: Staccato Prochlorperazine in Migraine (Out Patient)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Headache
Aura
Keywords: Migraine, Staccato Prochlorperazine
Migraine headache with or without aura.
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Headache Pain Relief at 2 hr
timeFrame: 2 hr post-dose
Secondary outcomes:
measure: Responders, Pain-Free at 2 Hours
timeFrame: 2 hours
measure: Survival of Headache Pain Relief
timeFrame: 0 to 4 hours
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Department of Neurology, Mayo Clinic
state: Arizona
city: San Francisco
country: United States
facility: San Francisco Headache Clinic
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Walnut Creek
country: United States
facility: Neurological Research Institute of East Bay
state: California
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut PC
state: Connecticut
city: Hartford
country: United States
facility: Hartford Headache Center
state: Connecticut
city: Stamford
country: United States
facility: The New England Center for Headache
state: Connecticut
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Wellesley Hills
country: United States
facility: Medvadis
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional Headache Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: The Michigan Head-Pain and Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: Headache Care Center Primary Care Network, INC
state: Missouri
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Mount Vernon
country: United States
facility: Elkind Headache Center
state: New York
city: New York
country: United States
facility: New York Headache Center
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates, PC
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Cleveland
country: United States
facility: Health Research Associates
state: Ohio
city: West Chester
country: United States
facility: ClinExcel Research
state: Ohio
city: Oklahoma City
country: United States
facility: University Neurologists/OUHSC
state: Oklahoma
city: Houston
country: United States
facility: Houston Headache Clinic
state: Texas
city: Seattle
country: United States
facility: Swedish Research Center
state: Washington
Study officials:
affiliation: Alexza Pharmaceuticals, Inc.
name: Daniel A Spyker, PhD, MD
role: STUDY_DIRECTOR
References: