A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.

Status Not yet recruiting

Clinical Trial Summary

This proof of concept clinical study will investigate the efficacy of active lens with frame in alleviating the symptoms of migraine which are caused by photosensitivity. The spectacles cut out blue light wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring.

Clinical Trial Description

Patients will be randomised to one of two groups: Group 1 1. Patients wear sham glasses for 4 weeks 2. Patients have 1 week's washout 3. Patients wear active glasses for 4 weeks Group 2 4. Patients wear active glasses for 4 weeks 5. Patients have 1 week's washout 6. Patients wear sham glasses for 4 weeks The study will aim to determine whether wearing the active lens successfully reduces the symptoms of migraine, compared to wearing sham lens. Assuming a fairly conservative SD in the primary endpoint of 8 points, a total of 56 participants would be required to have 90% power to detect a minimum clinically significant difference of 5 points in a two-sample t-test. Allowing for a 20% drop-out rate, 70 participants would need to be recruited. Patients will be in the trial for a total of 13 weeks (4 week run-in, two 4 week periods, with 1 week washout in between). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04904328
Study type	Interventional
Source	Mitsui Chemicals, Inc.
Contact	Yoshito Takeuchi
Phone	+81-90-4822-4960
Email	Yoshito.Takeuchi@mitsuichemicals.com
Status	Not yet recruiting
Phase	N/A
Start date	June 30, 2021
Completion date	April 4, 2022

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