UnknownNot Applicable

A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.

77 participantsStarted 2021-06-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Over 18 years old
✓. Diagnosis of migraine before the age of 50, confirmed though screening consultation with the patient
✓. Willing and able to provide written informed consent
✓. Willing to comply with study assessment schedule and patient diary entry
✓. Diagnosis of migraine, with or without aura based on the following primary headache characteristics (based on the Revised International Headache Society criteria for migraine headache)
✓. At least 5 attacks fulfilling criteria B-D
✓. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
✓. Headache has at least two of the following characteristics:

Exclusion criteria

✕. Patients with other light sensitive conditions, such as iritis or retinal disease.
✕. Patients who have less than 4 headache days per month
✕. Patients who have daily headaches.
✕. Pregnant or nursing
✕. History of cluster headache or hemiplegic migraine
✕. Evidence of seizure or major psychiatric disorder
✕. Score of 19 or higher on the BDI
✕. Active chronic pain syndrome

What they're measuring

Headache Impact Test 6

Timeframe: up to 13 weeks for each patients participation

Trial details

NCT IDNCT04904328

SponsorMitsui Chemicals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-04

Contact for this trial

Yoshito Takeuchi

+81-90-4822-4960 Yoshito.Takeuchi@mitsuichemicals.com

View on ClinicalTrials.gov More Migraine trials