Migraine Headache Mitigation Utilizing Avulux

NCT06149000 | Unknown FDA Device

• 1 other identifier: Avulux
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients

Conditions

Migraine; Headache; Photophobia

Outcome Measures

Primary Outcomes (2)

• Reduction in migraine frequency

  headache days per month documented in a headache diary.

  6 months

• Reduction in migraine severity

  Severity of headaches on a scale from no, mild, moderate, and sever pain

  6 months

Secondary Outcomes (2)

• Improve quality of life

  6 months

• Medication Use

  6 months

Study Arms (2)

Avulux Lenses

EXPERIMENTAL

This group will be receiving migraine treatment using Avulux lenses

Device: Avulux Lenses; Device: Placebo Lenses

Placebo Lenses

PLACEBO COMPARATOR

This group will be using identical placebo lenses as treatment

Device: Avulux Lenses; Device: Placebo Lenses

Interventions

Avulux Lenses DEVICE

Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines

Avulux Lenses; Placebo Lenses

Placebo Lenses DEVICE

Lenses that will look identical to Avulux lenses without the medical benefits

Avulux Lenses; Placebo Lenses

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G43. 10 (migraine w aura, not intractable).
• Only Kaiser Permanente members receiving care at the Fontana Medical Service Areas will be in consideration.
• Patients that are \>18
• There will no restrictions based on biological sex.
• Participants will be referred to optical by provider (Neurologists/Optometrist/Primary Care physician).
• Participants must agree to not initiate any new medical management during the trial or be willing to voluntarily withdrawal from participating in the trial

You may not qualify if:

• Patients who do not have a migraine diagnosis code in their medical record.
• Patients that have started a new migraine medication within last 30 days
• Non-Members of Kaiser Permanente

Sponsors & Collaborators

• Kaiser Permanente: lead

Related Publications (4)

• 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 BACKGROUND

• Katz BJ, Digre KB. Diagnosis, pathophysiology, and treatment of photophobia. Surv Ophthalmol. 2016 Jul-Aug;61(4):466-77. doi: 10.1016/j.survophthal.2016.02.001. Epub 2016 Feb 12.

  PMID: 26875996 BACKGROUND

• Wilkins AJ, Wilkinson P. A tint to reduce eye-strain from fluorescent lighting? Preliminary observations. Ophthalmic Physiol Opt. 1991 Apr;11(2):172-5. doi: 10.1111/j.1475-1313.1991.tb00217.x.

  PMID: 2062542 BACKGROUND

• Huang J, Zong X, Wilkins A, Jenkins B, Bozoki A, Cao Y. fMRI evidence that precision ophthalmic tints reduce cortical hyperactivation in migraine. Cephalalgia. 2011 Jun;31(8):925-36. doi: 10.1177/0333102411409076. Epub 2011 May 26.

  PMID: 21622479 BACKGROUND

Related Links

• Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience
• Avulux Randomized Trial

MeSH Terms

Conditions

Migraine Disorders; Headache; Photophobia

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Eye Diseases

Study Officials

• Munish Sharma, OD/MBA

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Aragon, MPH

CONTACT

323-812-5569; Leslie.A.Aragon@kp.org

Munish Sharma, OD/MBA

CONTACT

909-427-4452; Munish.Sharma@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participants or the researchers will know which treatment is being received during the trial. This will be achieved by using identical looking placebos for control and ensuring all aspects of the treatment administration and assessment are indistinguishable.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a randomized, double blind, crossover interventional trial. Participants will be randomly assigned to one of 2 groups of 20. 1. Experimental Group: Participants in this group will wear Avulux lenses during the testing sessions. 2. Control Group: Participants in this group will wear placebo lenses that resemble Avulux lenses but do not have the same optical properties.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 28, 2023
• Study Start: December 13, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 20, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share