DRKS00033341招募中Unknown
Effects of oxytocin receptor antagonization in migraine: A randomized, double-blind, placebo-controlled human provocation study - oxytocin and migraine
Charité Universtitätsmedizin Berlin0 个研究点目标入组 60 人开始时间: 2024年1月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Group 1: Women with migraine are eligible to be included in the study if all of the following criteria apply:
- •1. Confirmed episodic migraine based on the criteria of the IHS
- •2. 1-5 migraine days in the 28 days prior to study enrollment
- •3. Use of continuous hormonal contraception (i.e., no hormone-free interval) for at least 3 months
- •4. Age 18-45 years upon entry into screening.
- •Control 1: Men with migraine are eligible to be included in the study if all of the following criteria apply:
- •1. Confirmed episodic migraine based on the criteria of the International Headache Society (IHS)
- •1. 1-5 migraine days in the 28 days prior to study enrollment
- •2. Age 18-45 years upon entry into screening.
- •Control 2: Healthy female controls are eligible to be included in the study if all of the following criteria apply:
- •1. Use of continuous hormonal contraception (i.e., no hormone-free interval) for at least 3 months
- •2. Age 18-45 years upon entry into screening.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. History of any primary headache disorder other than migraine without aura (for participants with migraine), or tension-type headache with a frequency of <5 headache days per month before screening according to the IHS criteria, based on medical records and/or patient self-report.
- •2. History of any secondary headache disorder before screening, based on medical records and/or patient self-report.
- •3. Intake of prophylactic migraine medication within =30 days or 5 plasma half-lives (whichever is longer) prior to screening.
- •4. Intake of hormonal treatments other than hormonal contraception.
- •3. History or evidence of neurological disorders (e.g., multiple sclerosis, brain tumor, history of severe traumatic brain injury, history of brain surgery).
- •4. History or evidence of severe inflammatory diseases (infectious, rheumatic).
- •5. Evidence of arterial hypertension.
- •6. History or evidence of cardiovascular diseases (e.g., cerebral ischemia, coronary heart disease, history of myocardial infarction, peripheral arterial disease, severe heart valve disease).
- •7. Evidence of Diabetes mellitus.
- •8. Body Mass Index <18 or >30 kg/m2.
- •9. Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
- •10. History or evidence of severe psychiatric disorders.
- •11. Previous participation in a provocation study.
- •12. Initiation of any new medical treatment and/or device during study period results in exclusion.
- •13. Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants’ and investigator’s knowledge.
研究者
相似试验
进行中（未招募）
3 期
Comparison of the efficacy of oxtyocin agonist to oxytocin in the prevention of postpartum hemorrhage (PPH) in women undergoing vaginal deliveryvaginal deliveryvaginal delivery and blood lossReproductive Health and Childbirth - Childbirth and postnatal carePostpartum HemorrhageACTRN12608000396325Dr Farouk720
尚未招募
不适用
An investigation of the effects of oxytocin on communicatiosociaal gedragn.v.t.NL-OMON35456niversitair Medisch Centrum Sint Radboud80
已完成
3 期
A study to observe the effect of a drug Atosiban in patients undergoing embryo transfer procedure for in vitro fertilizatioCTRI/2017/09/009593Infertility Department200
终止
2 期
An investigation into the role of oxytocin in emotion after injury or traumaIndividuals who have experienced a traumatic injury.ACTRN12617001208392Monash University25
已完成
不适用
Comparison the effects of uterotonic constrictors in caesarean section under spinal anesthesiaCaesarean section.Delivery by caesarean section, unspecifiedIRCT201207055751N3Bushehr University of Medical Sciences80