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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341298
• Other study ID #: 20200480
• Status: Completed
• Phase: N/A
• Start date: April 6, 2020
• Est. completion date: August 26, 2020

Study information

• Verified date: April 2022
• Source: Avulux, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hours of device application, when compared to a control device.

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 optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines. The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Other:
• 11-point pain scale
Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.
• Headache diary
Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Device:
• Avulux®
Avulux® device
• Sham Avulux®
Sham Avulux®

Locations

Country	Name	City	State
United States	Endocrinology Research Associates, Inc.	Columbus	Ohio
United States	Remington-Davis Clinical Research	Columbus	Ohio
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Avulux, Inc.	Imarc Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)	Number of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe (i.e. baseline pain score of 6 or higher) to mild/no pain (defined as a pain score of 3 or less) after an elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.	from baseline to 2 hours after device application
Other	Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)	Number of subjects who require abortive headache medication (e.g. analgesic or triptan) to control their first severe or very severe migraine headache (i.e. baseline pain score of 6 or higher) within 8 hours following application of the device. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.	baseline to 8 hours after device application
Other	Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)	Number of subjects suffering from light sensitivity after elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.	2 hours after device application
Other	Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)	Number of subjects suffering from light sensitivity after elapsed time of 4 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.	4 hours after device application
Primary	Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)	Change in migraine pain from baseline to 2 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.	from baseline to 2 hours after device application
Secondary	Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)	Change in migraine pain from baseline to 4 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.	from baseline to four hours after device application