EUCTR2017-004828-29-IT进行中（未招募）1 期
A pilot, double-blind, randomized, placebo-controlled, dose finding, proof of concept study to evaluate efficacy, safety and tolerability of self- administered subcutaneous diclofenac sodium 25-50-75mg/1ml in the treatment of an acute migraine attack with headache. - 17I-DCsc09
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- All
入选标准
- •Subjects eligible for this study must meet all the following criteria:
- •1. Male and female, with an age between 18 and 65 years
- •2. Subjects with migraine with or without aura, according to ICHD-3criteria since at least 1 year and with 3 months of well documented retrospective history
- •3. Subjects with migraine onset before 50 years of age
- •4. Subjects with a history of migraine attacks typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and with migraine episodes separated by at least 48 hours of headache pain freedom
- •5. Subjects with history of 2 to 8 migraine attacks per month with moderate to severe headache
- •6. Subjects with no more than 15 days of headache per month
- •7. Subjects on prophylactic migraine medication (no more than 1 prophylactic agent) on a stable dose for at least 3 months prior to study entry. If prophylaxis has been withdrawn, this should have been at least 1 month prior to inclusion or longer for compounds with long half-lives or that accumulate
- •8. Any female subject of childbearing potential must use adequate methods of contraception throughout the course of the study.
- •9. Subjects able to understand and comply with all study procedures
- •10. Subjects who have signed written informed consent prior to inclusion into the study.
- •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 128
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects eligible for the study must not meet any of the following criteria:
- •1. Subjects with major depression, schizophrenia, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
- •2. Subjects with actual acute pain syndromes
- •3. Subjects taking medications suspected to interfere with the IMP or known to interfere with the IMP if the pathology under treatment is unstable and if, in the Investigator’s opinion, the concurrent administration of the IMP during the study may be contraindicated
- •4. Subjects with presence of anaemia
- •5. Subjects with a history or evidence of asthma
- •6. Subjects with uncontrolled blood hypertension with significant cardiac impairment (i.e heart failure, severe ischemic heart disease) history or cerebrovascular diseases (i.e. ictus), history of peripheral arterial disease
- •7. Subjects with impaired hepatic or renal function, on the basis of out of range blood and urine analyses.
- •8. Subjects with a history of congenital bleeding diathesis (e.g., haemophilia) or any active clinically significant bleeding, or have any underlying platelet dysfunction including (e.g. idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction)
- •9. Subjects with a history of allergy or hypersensitivity to any component of aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
- •10. Subjects administered with NSAIDs, triptans, ergotamine, opioids, or combination analgesics as medication for acute treatment of headache for 15 or more days per month in the previous month
- •11. Pregnant or nursing women
- •12. Subjects who have participated in an investigational drug trial in the month prior to the inclusion in the study protocol.
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