NCT00489476已完成2 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Migraine Headache
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours
研究概览
简要总结
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
详细描述
This study will enroll male and female patients with migraine headache with or without aura. The study will randomize ~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients between the ages of 18 to 65 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 in the last month).
- •Patients who have been pain free for at least 48 hours since the end of their last migraine attack.
- •Patients who have not taken any acute migraine or pain medication within 48 hours prior to dosing (including OTC products).
- •Patients who have a pain rating of Moderate or Severe (on a None-Mild- Moderate-Severe Scale) prior to dosing.
- •Patients who speak, read, and understand English 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 to comply with the study schedule and requirements, are willing and able to travel to the Clinical Research Unit (CRU) for treatment and stay at the CRU for approximately a 4-6 hour period, 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 antipsychotics, tricyclic antidepressants, valproate, barbiturates, benzodiazepines, or lithium 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 dibenzoxazepines (loxapine and amoxapine) must be excluded.
- •Patients with a history of extra-pyramidal disorders, movement disorders including Parkinson's disease, and patients with a history of neuroleptic malignant syndrome must be excluded.
- •Female patients who have a positive pregnancy test at screening or during randomization visit, 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 syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded.
- •Patients who have a history of a major neurological disorder other than migraine (seizure disorder, subarachnoid 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 are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.
研究组 & 干预措施
2.5 mg Staccato Loxapine
Experimental
2.5 mg ADASUVE, single dose
干预措施: Staccato Loxapine (Drug)
1.25 mg Staccato Loxapine
Experimental
1.25 mg ADASUVE, single dose
干预措施: Staccato Loxapine (Drug)
5 mg Staccato Loxapine
Experimental
5 mg ADASUVE, single dose
干预措施: Staccato Loxapine (Drug)
Staccato Placebo
Experimental
Staccato Placebo, 0 mg
干预措施: Staccato Placebo (Drug)
结局指标
主要结局
Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours
时间窗: Baseline and 2 h post-dose
The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD. Intent to treat (ITT) with last observation carried forward (LOCF)
次要结局
- Pain-free at 2 Hours(Baseline and 2 h post-dose)
研究者
研究点 (1)
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