EUCTR2004-004999-36-DE进行中（未招募）不适用
Effects of Frovatriptan as Prophylactic Treatment of Cluster Headache, a Multi-Center, Placebo Controlled, Randomized, Double-Blind Prospective Phase III Parallel-Group Trial Comparing Frovatriptan with Placebo
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Patients must meet all of the following inclusion criteria that are to be determined at visit 1, day –7 (Run-in), to be considered eligible for study entry:
- •1.Written informed consent
- •2.Age between 18 and 65 years
- •3.Known episodic cluster headache, diagnosed according to the criteria of the International Headache Society (IHS)11; duration of an individual attack lasting between 15 minutes and 180 minutes, localisation strictly unilateral, cluster headache intensity at least moderate
- •4.At least second episode of cluster headache
- •5.Duration since onset of first attack of the current episode at least one week
- •6.Expected duration of cluster episode at least 6 weeks after start of screening
- •7.Response to oxygen inhalation (relevant change in headache severity)
- •Additionally, the patient has to meet the following inclusion criterion that is to be determined at visit 2, day 0 (baseline, randomisation):
- •Attack frequency between one attack every two days and eight attacks per day
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must not meet any of the following exclusion criteria to be considered eligible for study entry:
- •1.Any form of cluster headache other than episodic cluster headache
- •2.History of alcohol and/or drug and/or substance abuse
- •3.Progressive neurologic disease, i.e. cerebral tumours or structural brain damage caused by a birth defect, trauma, or infection
- •4.History of myocardial infarction, coronary vasospasm (e.g., Prinzmetal’s angina)
- •5.History or signs or symptoms of ischaemic heart disease
- •6.Stage II hypertension (SBP ³ 160 mmHg or DBP ³ 100 mmHg) or uncontrolled stage I hypertension (according to JNC)
- •7.History of peripheral vascular disease
- •8.Condition following apoplexy or history of transient ischaemic attack
- •9.Severe hepatic insufficiency (Child-Pugh C)
- •10.Severe renal insufficiency
- •11.Congenital disorders like Galactosaemia, Lactase deficiency or Glucose-Galactose malabsorption
- •12.Clinically significant psychiatric diseases
- •13.Known hypersensitivity to triptans or any of the ingredients of the study medication
- •14.Previous prophylactic treatment of cluster headache with frovatriptan within the last 30 days
- •15.Previous treatment within 6 months prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, for example
- •a) antipsychotic drugs
- •b) antidepressant drugs
- •16.Prophylactic and concomitant treatment of cluster headache e.g., verapamil, lithium, valproic acid (divalproex sodium), topiramate, gabapentin, lamotrigine, melatonin changed within one month prior to Visit 1 or changed during the study
- •17.Prophylactic and concomitant treatment with corticosteroids, civamide or botulinum toxin A
- •18.Previous treatment within 24 hours prior to the beginning of the study or concomitant treatment with other triptans (including treatment of acute attacks with subcutaneous sumatriptan)
- •19.Previous treatment within 24 hours prior to the beginning of the study or concomitant treatment with ergotamine, ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine(5-HT1)-receptor agonists
- •20.Concomitant anaesthesia of the greater optical nerve
- •21.Concomitant treatment with herbal remedies containing St. John’s Wort
- •22.Women of childbearing potential without adequate contraception; Medically acceptable methods are those with a failure rate less than 1% per year, such as contraceptive implant, contraceptive injection, some intrauterine devices (IUD), or combined oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study
- •23.Current participation in another clinical study or patients who have received an investigational drug within 30 days prior to entering the study
- •24.Patients who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial
- •25.Known HIV, HBV or HCV infection
研究者
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