Treatment of Acute Migraine when Pain is Mild versus when Pain is Moderate to Severe: an Almotriptan Parallel, Placebo Controlled Clinical Trial Act when mild?”

Almirall Prodesfarma, S.A.0 个研究点目标入组 484 人开始时间: 2005年6月21日最近更新: 2019年11月25日

试验速览

暂无简介。

•1. Subjects must have a history of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria for the classification of migraine with or without aura for at least one year.
•2. Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year.
•3. Patients must have a migraine headache frequency of 2 to 6 per month for the past 3 months.
•4. Patients must have had a history of duration of untreated or unsuccessfully treated migraine headache of 4 hours or longer in the past.
•5. Patients must be male or female aged 18 to 65 years.
•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

•1. Patients, who in the opinion of the investigator, should not be enrolled in the trial because of the precautions, warnings or contraindications sections of the almotriptan Summary of Product Characteristics (see Appendix 3 of the protocol).
•2. Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months.
•3. Patients with onset of migraine after age 50.
•4. Patients who routinely experience any other type of headache that would confound discrimination from a migraine headache (e.g., headaches related to allergies, food, alcohol, and/or medications, sinus headaches, withdrawal headaches related to changes in the normal intake of substances such as caffeine or nicotine, rebound headaches due to overuse of certain headache medications), or tension-type headache for more than four days per month for the past 3 months.

发起方

Almirall Prodesfarma, S.A.