Staccato Prochlorperazine in Migraine (Out Patient)

NCT00422812 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AMDC-001-202
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 25

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.

Conditions

Migraine Headache; Aura

Keywords

Migraine, Staccato Prochlorperazine; Migraine headache with or without aura.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responders, Pain-Free at 2 Hours

  2 hours

• Survival of Headache Pain Relief

  0 to 4 hours

Study Arms (4)

Inhaled Placebo

PLACEBO COMPARATOR

Inhaled Staccato Placebo

Drug: Inhaled Placebo

Inhaled PCZ 5 mg

EXPERIMENTAL

Inhaled Staccato Prochlorperazine 5 mg

Drug: Inhaled PCZ 5 mg

Inhaled PCZ 7.5 mg

EXPERIMENTAL

Inhaled Staccato Prochlorperazine 7.5 mg

Drug: Inhaled PCZ 7.5 mg

Inhaled PCZ 10 mg

EXPERIMENTAL

Inhaled Staccato Prochlorperazine 10 mg

Drug: Inhaled PCZ 10 mg

Interventions

Inhaled Placebo DRUG

Inhaled Staccato Placebo

Inhaled Placebo

Inhaled PCZ 5 mg DRUG

Inhaled Staccato Prochlorperazine 5 mg

Inhaled PCZ 5 mg

Inhaled PCZ 7.5 mg DRUG

Inhaled Staccato Prochlorperazine 7.5 mg

Inhaled PCZ 7.5 mg

Inhaled PCZ 10 mg DRUG

Inhaled Staccato Prochlorperazine 10 mg

Inhaled PCZ 10 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between the ages of 18 to 70 years, inclusive.
• Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Patients who are currently taking tricyclic antidepressants, valproate, divalproex, barbitals, thiazolidinediones, phenothiazines, benzodiazepines, lithium or any hepatic toxic drugs must be excluded.
• Patients who are currently taking medications that prolong the QT/QTc interval (see Appendix 4) must be excluded.
• Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded.
• Patients with a history of allergy or intolerance to phenothiazines and related drugs (prochlorperazine, chlorpromazine, promethazine, mesoridazine, thioridazine, fluphenazine, perphenazine) must be excluded.
• Patients with a history of extra-pyramidal disorders, movement disorders, neuroleptic malignant syndrome, or major affective disorder must be excluded.
• Female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
• Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
• Patients who have a history of pheochromocytoma, seizure disorder or Parkinson's disease must be excluded.
• Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 mos), congestive heart failure, or transient ischemic attack must be excluded.
• Patients who have a history of a major neurological disorder other than migraine (subarachnoidal bleeding, stroke, brain tumor) must be excluded.
• 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.
• Patients who have a history of asthma or chronic obstructive lung disease should be excluded.
• Patients who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
• 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.
• 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.

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (25)

Department of Neurology, Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

San Francisco Headache Clinic

San Francisco, California, 94109, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Neurological Research Institute of East Bay

Walnut Creek, California, 94596, United States

Location

Mile High Research Center

Denver, Colorado, 80218-1110, United States

Location

Associated Neurologists of Southern Connecticut PC

Fairfield, Connecticut, 06824, United States

Location

Hartford Headache Center

Hartford, Connecticut, 06106, United States

Location

The New England Center for Headache

Stamford, Connecticut, 06902, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Palm Beach Neurological Center

West Palm Beach, Florida, 33410, United States

Location

Diamond Headache Clinic

Chicago, Illinois, 60614-1726, United States

Location

Medvadis

Wellesley Hills, Massachusetts, 02481-2106, United States

Location

New England Regional Headache Center

Worcester, Massachusetts, 01605, United States

Location

The Michigan Head-Pain and Neurological Institute

Ann Arbor, Michigan, 48104.5199, United States

Location

Headache Care Center Primary Care Network, INC

Springfield, Missouri, 65807, United States

Location

Regional Clinical Research

Endwell, New York, 13760, United States

Location

Elkind Headache Center

Mount Vernon, New York, 10050, United States

Location

New York Headache Center

New York, New York, 10021, United States

Location

Island Neurological Associates, PC

Plainview, New York, 11803, United States

Location

PharmQuest

Greensboro, North Carolina, 27401, United States

Location

Health Research Associates

Cleveland, Ohio, 44121, United States

Location

ClinExcel Research

West Chester, Ohio, 45069, United States

Location

University Neurologists/OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

Houston Headache Clinic

Houston, Texas, 77004, United States

Location

Swedish Research Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Epilepsy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Executive VP, Research & Development, Regulatory & Quality
• Organization: Alexza Pharmaceuticals, Inc

ClinicalTrialsInfo@alexza.com

650.944.7071

Study Officials

• Daniel A Spyker, PhD, MD

  Alexza Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 17, 2007
• Study Start: April 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: January 25, 2018
• Results First Posted: January 25, 2018

Record last verified: 2008-06

Data Sharing

• IPD Sharing: Will share

Locations

US (25)