ViKEM

Not Applicable

Conditions: Episodic migraine headache among adult subjects.
Migraine

Registration Number: LBCTR2023075403

Lead Sponsor: Sola Aoun Bahous

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 160

Inclusion Criteria

adults subjects, 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, patients who take 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 oral vitamin K antagonists, other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, postherpetic neuralgia…), history of hypersensitivity to the vitamin K2, history of soy protein allergy, history of thrombotic events, diagnosed coagulopathy, 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. or acute illness in the past month.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ame: Changes of monthly migraine days;Timepoints: 6 months;Measure: aquestionnaire to be administered at the start, monthly, and at the end of the study (6months) about frequency and number of migraine days per month.

Secondary Outcome Measures

Name	Time	Method
ame: Changes from baseline in the headache impact score;Timepoints: 3 & 6 months;Measure: HIT-6;Name: Changes from baseline in monthly severe migraine days;Timepoints: 3 & 6 months;Measure: visual analogue rating scale;Name: Changes from baseline on the modifi ed migraine disability assessment;Timepoints: 3 & 6 months;Measure: MIDAS;Name: Changes from baseline on the modified migraine physical function impact diary;Timepoints: 3 & 6 months;Measure: MPFID;Name: Changes from baseline on the quality of life;Timepoints: 3 & 6 months;Measure: EuroQoL;Name: Changes of arterial stiffness level;Timepoints: 3 & 6 months;Measure: cfPWV