Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

The purpose of this research is to assess how well the Avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.

Key facts

Study ID

NCT04341298

Run by

Avulux, Inc.

People needed

78

Starts

2020-04-06

Expected to finish

2020-08-26

Last updated by the study team

2023-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is 18 years or older
• Subject is willing and able to provide written informed consent
• Diagnosis of migraine, based on a history of at least 5 attacks per month with the following primary headache characteristics:
• 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 (e.g. walking or climbing stairs)
• Headache occurs with at least one of the following symptoms:
• nausea and/or vomiting
• photophobia and phonophobia
• Subject has experienced at least 4 migraine attacks in the last month, with at least two migraine attacks resulting in severe pain prior to the use of any abortive medications
• Migraines are not attributed to another disorder

You may not qualify if…

• Subjects participating in another prospective, interventional clinical study
• Subjects with other light sensitive conditions, such as iritis
• Subjects who have less than 4 headache days per month with the above characteristics
• Chronic migraine subjects (defined as subjects who experience a minimum of 15 headache days per month)
• Subjects with headaches due to medication overuse (defined as regular use of headache medication for a minimum of 10 days per month, for a minimum period of 3 months)
• Subjects who have had any change in their migraine treatment within 4 weeks prior to study enrollment
• Subjects whose family members are currently participating in this study, or are employees of the study site, Avulux, or the coordinating CRO

Where it is running

• Clinical Research Institute, Inc. — Minneapolis, Minnesota, United States
• Endocrinology Research Associates, Inc. — Columbus, Ohio, United States
• Remington-Davis Clinical Research — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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