Status:
COMPLETED
Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Lead Sponsor:
Avulux, Inc.
Collaborating Sponsors:
Imarc Research, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with episodic migraine headaches. In this study, the investigative Avulux® device shall consist of a pair of opt...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2020
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04341298
Start Date
April 6 2020
End Date
August 26 2020
Last Update
January 9 2023
Active Locations (3)
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1
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States, 55402
2
Endocrinology Research Associates, Inc.
Columbus, Ohio, United States, 43201
3
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215