Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT02315833
Eligibility Criteria:
Inclusion Criteria:
* 18-65 years male/female
* subjects should report migraine attacks with the frequency of 2-8 times per month, and with less than 15 migraine days (NMD) per month. To be calculated as a separate attack, there should be at least 48h of freedom from headache between the two attacks of migraine.
* migraine with or without aura has been present for at least 1 year prior to entering into the study
* subjects to be enrolled should report the onset of their migraine before 50 years of age
Exclusion Criteria:
* patients who meet the International Classification of Headache Disorders II criteria for medication overuse
* patients who have taken anti-psychotics or anti-depressant medications during the previous 3 months
* patients who abuse alcohol or other drugs
* patients resistant to all acute migraine drugs optimally prescribed
* potentially fertile and sexually active women who do not practise contraception
* other acute or chronic pain disorders
* severe psychiatric disease
* infection
* malignancy
* short life expectancy
* cardiovascular disease
* cerebrovascular disease
* uncontrolled hypertension
* degenerative central nervous system diseases
* pregnant and lactating women
* regular users of Acetium capsules for other indications
* persons suffering from renal dysfunction or cystinuria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02315833
Study Brief:
Protocol Section:
NCT02315833