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

NCT ID: NCT04341298

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2020-08-26

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.

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

11-point pain scale

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Avulux®

Intervention Type: DEVICE

Avulux® device

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.

Group Type: SHAM_COMPARATOR

11-point pain scale

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Sham Avulux®

Intervention Type: DEVICE

Sham Avulux®

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Avulux®

Avulux® device

Intervention Type: DEVICE

Sham Avulux®

Sham Avulux®

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imarc Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Avulux, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Institute, Inc.

Minneapolis, Minnesota, United States

Endocrinology Research Associates, Inc.

Columbus, Ohio, United States

Remington-Davis Clinical Research

Columbus, Ohio, United States

Countries

United States

References

Posternack C, Kupchak P, Capriolo AI, Katz BJ. Targeting the intrinsically photosensitive retinal ganglion cell to reduce headache pain and light sensitivity in migraine: A randomized double-blind trial. J Clin Neurosci. 2023 Jul;113:22-31. doi: 10.1016/j.jocn.2023.04.015. Epub 2023 May 5.

Reference Type: DERIVED

PMID: 37150129 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20200480

Identifier Type: -

Identifier Source: org_study_id