A Multicentric, Double-blind, Randomized, Comparative, Parallel-group, Sumatriptan-Controlled Phase III Clinical Trial of the Safety and Efficacy of Almotriptan oral tablets in patients with Migraine Headache

MSN Laboratories Ltd ,115,2 RT (7-1-621/39)2nd Floor, Sanjeeva Reddy Nagar,Hyderabad-5000380 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

入选标准

•All subjects with duly filled and signed in ICFs [Informed Consent Forms]
•Male and female outpatients Â³ 18 years of age.
•Diagnosis of migraine, with or without aura
•At least moderate pain with migraines
•Average of 2 to 6 migraines per month for past 3 months
•Duration of headache pain at least 4 hours
•Able to tell the difference between a migraine and a tension headache
•If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening
•In generally good health
•If female, using birth control
•Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.

排除标准

•Patients unwilling to sign on ICF
•Routinely experience other type of headache that might seem like a migraine headache
•An average of 15 or more headache days per month in the past 6 months
•Migraines began after age 50
•Taking 1 medicine for preventing migraines
•Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days
•Use of non-drug treatment for migraine in past 14 days unless have used this treatment for 14 days and plan to continue throughout study
•Overuse of medications that treat pain or nausea
•Migraine aura without headache
•Hemiplegic or basilar migraines
•Usually have vomiting with headache
•Headaches that usually occur upon waking
•Significant unstable medical disease
•Abusing drugs or alcohol
•History of a significant mental disorder
•Pregnant or breast-feeding
•Patients with clinically significant or unstable hepatic, respiratory, or hematologic illnesses, unstable cardiovascular disease, or symptomatic peripheral vascular disease.
•Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
•Patients with an estimated creatinine clearance of 60 mL/minute based on serum creatinine levels will be excluded.
•Patient?s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.
•Patients being treated with any of the excluded medications mentioned in the protocol.
•Patients with concomitant diseases such as malignancy, HIV
•Participation in other trials or Previous participation in this or any other almotriptan clinical trial

研究者

发起方

MSN Laboratories Ltd ,115,2 RT (7-1-621/39)2nd Floor, Sanjeeva Reddy Nagar,Hyderabad-500038

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