Staccato Prochlorperazine in Migraine (Out Patient)

Migraine Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422812
• Other study ID #: AMDC-001-202
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2007
• Last updated: June 16, 2017
• Start date: April 2006
• Est. completion date: January 2007

Study information

• Verified date: June 2008
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aura
• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	The Michigan Head-Pain and Neurological Institute	Ann Arbor	Michigan
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Health Research Associates	Cleveland	Ohio
United States	Mile High Research Center	Denver	Colorado
United States	Regional Clinical Research	Endwell	New York
United States	Associated Neurologists of Southern Connecticut PC	Fairfield	Connecticut
United States	PharmQuest	Greensboro	North Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Hartford Headache Center	Hartford	Connecticut
United States	Houston Headache Clinic	Houston	Texas
United States	Elkind Headache Center	Mount Vernon	New York
United States	New York Headache Center	New York	New York
United States	University Neurologists/OUHSC	Oklahoma City	Oklahoma
United States	Island Neurological Associates, PC	Plainview	New York
United States	San Francisco Headache Clinic	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Department of Neurology, Mayo Clinic	Scottsdale	Arizona
United States	Swedish Research Center	Seattle	Washington
United States	Headache Care Center Primary Care Network, INC	Springfield	Missouri
United States	The New England Center for Headache	Stamford	Connecticut
United States	Neurological Research Institute of East Bay	Walnut Creek	California
United States	Medvadis	Wellesley Hills	Massachusetts
United States	ClinExcel Research	West Chester	Ohio
United States	Palm Beach Neurological Center	West Palm Beach	Florida
United States	New England Regional Headache Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Pain Relief at 2 hr	Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),	2 hr post-dose
Secondary	Responders, Pain-Free at 2 Hours	Percentage of Responders, Pain-Free, by Treatment Group over Time	2 hours
Secondary	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 a=0.05.	0 to 4 hours