EUCTR2019-001081-15-FI进行中（未招募）1 期
An exploratory phase II, randomised, double-blind, placebo-controlled, parallel-group study investigating the efficacy and safety of Sepranolone in women with menstrual migraine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Main Inclusion Criteria
- •The woman must:
- •1.provide her informed consent prior to any study related procedures
- •2.be aged =18 and =45 years.
- •3.have a regular menstrual cycle of 24-35 days
- •4.use sufficient barrier contraception, non-hormonal IUD, be truly abstinent or the woman or her male sexual partner has been surgically sterilized (further described in Section 4.3.1).
- •5.have a history of migraine according to the IHS classification ICHD-3 with a history of at least 12 months with migraine in conjunction with menstruation and in at least 2 out of 3 ovulatory menstrual cycles.
- •6.for randomisation, have documented menstrual migraine attacks during at least two menstrual cycles out of the three-cycle screening and baseline period. A menstrual migraine attack is defined as starting at a time between Day -2 and Day +3 of full menstrual flow (limits inclusionary)
- •Further, the woman may
- •7.have a total of maximum ten (10) migraine or other headache days per month.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Main Exclusion Criteria
- •The woman must not have:
- •1.participated in a clinical study and received active drug in such a study within 30 days or 5 study drug half-lives, whichever the longest, prior to the first study visit.
- •2.in the investigator's opinion, evidence and/or history of any clinically significant neurological disease, other intracranial or systemic diseases or conditions potentially interfering with study assessments
- •3.a BMI >35 kg/m2.
- •4.or has had a malignant disease within the previous 5 years (except non-melanoma skin cancer, cervical or breast ductal carcinoma in situ)
- •5.HIV or ongoing hepatitis by history
- •6.have allergies to ingoing study drug components or a history of anaphylactic reactions.
- •7.have a less than 80% compliance with eDiary reporting during Days -7 until + 7 in each of the three-cycle baseline periods.
- •The woman must not be:
- •8.suffering any other medically significant and unstable disease potentially interfering with or being negatively affected by participation in the study, as judged by the investigator.
- •9.pregnant or breast-feeding, or planning pregnancy during the study period
- •10.taking any systemic steroid hormonal treatment (including hormonal IUD) during 3 months before the study visit. Topical corticosteroids and stable doses of inhalational treatment for asthma or seasonal allergy may be allowed. For injectable hormonal contraceptives, a 6-month washout is required.
- •11.previously been diagnosed with a major psychiatric disorder according to DSM 5® criteria, including drug abuse or dependency
- •12.taking disallowed medications or allowed with restrictions with respect to their use prior to or during the study (this list is not comprehensive). Disallowed medications include: corticosteroids, OCTs, over-the-counter or prescription drugs for PMS symptoms, including but not limited to, bioidentical hormones, St John’s wort, Evening primrose oil, Agnus castor.
研究者
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