Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Benfida, a department of Handi-Move
With
Artialis
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female between 18 and 75 years;
Diagnosis of migraine meeting the criteria of the International Classification of Headache Disorders (ICHD-3) (with or without aura)
* At least 5 attacks fulfilling the criteria below
* Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
* Headache has at least two of the following characteristics
* unilateral location
* pulsating quality
* moderate or severe pain intensity
* aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
* During headache at least one of the following:
* nausea and/or vomiting
* photophobia and phonophobia
* Not attributed to another disorder
Migraine frequency of at least 6 headache days per month during the last 3 months;
Stable body mass index (BMI) between 18.5-35.0;
Stable medication use with no significant changes in prophylactic or acute migraine treatments in the past 3 months, and willingness to maintain or reduce (if not needed) this throughout the study period;
Willingness and ability to complete an ediary (mobile app or web based) and to follow the instruction of the study;
Having signed an informed consent.
You may not be if
Other primary head pain disorders such as but not restricted to tension-type headache, cluster headache, fibromyalgia;
Secondary head pain due to trauma, injury, infections;
Medication overuse for headache defined as acute headache medication \>10-15 days per month depending on the half-life of the medication (left to PI discretion);
Severe medical conditions affecting absorption and metabolism of the product, including but not restricted to chronic use of laxatives;
Bariatric surgery;
Severe psychiatric conditions that could interfere with diary compliance or assessment of the product (e.g., severe depression or cognitive impairments) left to investigator discretion;
Use of other dietary supplements that could potentially affect migraines, unless willing to discontinue them before the study begins (wash out period of 3 months);
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
Women of childbearing potential without medically effective form of contraception unless they can confirm they've had bilateral tubal ligation or that their male partner has had a vasectomy;
Specific allergies or intolerance to components of the product;
Recent migraine interventions: Such as Botox injections (except if considered as a stable treatment, i.e. not the first injection), nerve blocks, or other invasive treatments in the last 6 months;
Concurrent participation in another clinical study or having participated in the last 3 months:
Swallowing disorders;
Chronic drug and alcohol abuse;
Anticoagulants (coumarin compound);
Hepatic or biliar truct disorders;
Active malignancy and immunosuppression therapy;
Hypothyroidism;
Close collaborators of investigational team, of sponsor or of study coordinator;
