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:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT05943457
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years or above
* History of episodic migraine with or without aura since \> 12 months according to the ICHD-3 criteria.
* Migraine frequency from 4-14 days per month over the 3 months prior to screening.
* Migraine frequency from 4-14 days per month during the baseline period of assessment.
* Successful completion of the migraine diary during the baseline evaluation period.
Exclusion Criteria:
* Migraine patients with superimposed tension type or other forms of primary headaches
* Patients who are currently on any of the migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)
* Patients who have been on any of the previously listed medications within 3 months of screening
* Patient who takes the following medications:
* Ergotamine or Triptans \> 10 days per month
* NSAIDs or paracetamol \> 15 days per month
* Opioids more than 4 days per month
* Patients on anticoagulants
* Other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia…)
* History of hypersensitivity to the vitamin K2
* History of soy protein, cheese, eggs and meat allergy
* History of thrombotic events
* Diagnosed coagulopathy or any condition related to coagulation
* Cardiovascular event in the past month
* Current or planned pregnancy
* Lactation
* Inability to tolerate oral medications
* Known intestinal malabsorption or hypomotility syndromes
* Atrial fibrillation
* Active malignancy
* Any acute illness in the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05943457
Study Brief:
Protocol Section:
NCT05943457