Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.

Key facts

Study ID

NCT03902496

Run by

Avulux, Inc.

People needed

60

Starts

2019-03-18

Expected to finish

2019-05-17

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 18 years or older
• Patient is willing and able to provide written informed consent
• Patient is willing and able to complete all scheduled study visits
• Diagnosis of migraine, based on the following primary headache characteristics:
• 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:
• unilateral location
• pulsating quality
• moderate or severe pain intensity
• aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
• During headache at least one of the following:
• nausea and/or vomiting
• photophobia and phonophobia
• Not attributed to another disorder

You may not qualify if…

• Patients with other light sensitive conditions, such as iritis.
• Patients who have less than 4 headache days per month
• Patients who have chronic daily headaches.
• Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.

Where it is running

• Remington-Davis Clinical Research — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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