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

• ClinicalTrials.gov Identifier: NCT04341298
• Recruitment Status: Completed
• First Posted: April 10, 2020
• Results First Posted: January 9, 2023
• Last Update Posted: January 9, 2023
• Sponsor: Avulux, Inc.
• Collaborator: Imarc Research, Inc.
• Information provided by (Responsible Party): Avulux, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Migraine	Other: 11-point pain scale; Other: Headache diary; Device: Avulux®; Device: Sham Avulux®	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
• Masking: Triple (Participant, Care Provider, Investigator)

Masking Description

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.

• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
• Actual Study Start Date: April 6, 2020
• Actual Primary Completion Date: August 26, 2020
• Actual Study Completion Date: August 26, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Avulux® device; Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.	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.; Other: 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 Comparator: Control/sham device; Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.	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.; Other: 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: Sham Avulux®; Sham Avulux®

Outcome Measures

Primary Outcome Measures :

1. Change in 11-point Pain Scale Score After Two Hours (First Severe Headache) [ Time Frame: from baseline to 2 hours after device application ]
   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.

Secondary Outcome Measures :

1. Change in 11-point Pain Scale Score After Four Hours (First Severe Headache) [ Time Frame: from baseline to four hours after device application ]
   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.

Other Outcome Measures:

1. Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache) [ Time Frame: from baseline to 2 hours after device application ]
   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.
2. Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache) [ Time Frame: baseline to 8 hours after device application ]
   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.
3. Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache) [ Time Frame: 2 hours after device application ]
   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.
4. Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache) [ Time Frame: 4 hours after device application ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

Clinical Research Institute, Inc.

Minneapolis, Minnesota, United States, 55402

United States, Ohio

Endocrinology Research Associates, Inc.

Columbus, Ohio, United States, 43201

Remington-Davis Clinical Research

Columbus, Ohio, United States, 43215

Sponsors and Collaborators

Avulux, Inc.

Imarc Research, Inc.

  Study Documents (Full-Text)

Documents provided by Avulux, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] February 21, 2020

More Information

• Responsible Party: Avulux, Inc.
• ClinicalTrials.gov Identifier: NCT04341298
• Other Study ID Numbers: 20200480
• First Posted: April 10, 2020
• Results First Posted: January 9, 2023
• Last Update Posted: January 9, 2023
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Migraine Disorders; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations