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

NCT04341298 | Completed Results

• 1 other identifier: 20200480
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)

  from baseline to four hours after device application

Other Outcomes (4)

• Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)

  from baseline to 2 hours after device application

• Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)

  baseline to 8 hours after device application

• Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)

  2 hours after device application

Study Arms (2)

Avulux® device

EXPERIMENTAL

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; Other: Headache diary; Device: Avulux®

Control/sham device

SHAM COMPARATOR

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; Other: Headache diary; Device: Sham Avulux®

Interventions

11-point pain scale 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.

Avulux® device; Control/sham device

Headache diary 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® device; Control/sham device

Avulux® DEVICE

Avulux® device

Avulux® device

Sham Avulux® DEVICE

Sham Avulux®

Control/sham device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Avulux, Inc.: lead
• Imarc Research, Inc.: collaborator

Study Sites (3)

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Endocrinology Research Associates, Inc.

Columbus, Ohio, 43201, United States

Location

Remington-Davis Clinical Research

Columbus, Ohio, 43215, United States

Location

Related Publications (1)

• 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.

  PMID: 37150129 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Charles Posternack, President
• Organization: Avulux

cposternack@avulux.com

833-288-5890

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: April 6, 2020
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: January 9, 2023
• Results First Posted: January 9, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)