NCT01839149已完成2 期
A Phase 2, Enriched-enrollment, Randomized-withdrawal, Double-blinded, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Intranasal Oxytocin in Subjects With Chronic Migraine
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
- 240
- 主要终点
- Mean change of migraine days
研究概览
简要总结
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
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
- 否
入选标准
- •Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
排除标准
- •Known allergy to oxytocin
- •History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
- •History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
- •Have basilar or hemiplegic migraines
- •Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
- •Have a nasal obstruction due to any cause
- •Are pregnant or breast feeding
- •Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs
- •Are unable or unwilling to provide informed consent or to follow study procedures
研究组 & 干预措施
TI-001 (intranasal oxytocin)
Experimental
TI-001 is intranasal oxytocin
干预措施: TI-001 (Drug)
Placebo
Placebo Comparator
Placebo for TI-001 is the same intranasal formulation without oxytocin
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change of migraine days
时间窗: Baseline and 28 days of treatment
Baseline is the 28-day screening period before study drug administration
次要结局
- Mean change of moderate or severe headache days(Baseline and 28 days of treatment)
- Proportion of subjects experiencing a ≥50% reduction in migraine days(Baseline and 28 days of treatment)
- Mean change in days using rescue medication(Baseline and 28 days of treatment)
- Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing(Baseline and 28 days of treatment)
研究者
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