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Clinical Trials/LBCTR2023075403
LBCTR2023075403Not yet recruiting未知

Vitamin K2 Supplementation in Adult Episodic Migraine

Sola Aoun Bahous0 sites160 target enrollmentStarted: February 6, 2024Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Not yet recruiting
Sponsor
Enrollment
160

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 to 100 (—)
Sex
All

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.

Investigators

Sponsor
Sola Aoun Bahous

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