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

Alexza Pharmaceuticals, Inc.25 个研究点分布在 1 个国家目标入组 400 人2006年4月

适应症Migraine Headache Aura

干预措施Inhaled Placebo Inhaled PCZ 5 mg Inhaled PCZ 7.5 mg Inhaled PCZ 10 mg

概览

阶段: 2 期
干预措施: Inhaled Placebo
疾病 / 适应症: Migraine Headache
发起方: Alexza Pharmaceuticals, Inc.
入组人数: 400
试验地点: 25
主要终点: Headache Pain Relief at 2 hr
状态: 已完成
最后更新: 8年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2006年4月

结束日期

2007年1月

最后更新

8年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Alexza Pharmaceuticals, Inc.

责任方

Sponsor

入排标准

入选标准

•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.

排除标准

•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.