MigraineNCT06149000
Migraine Headache Mitigation Utilizing Avulux
A study testing Avulux Lenses in people with Migraine and Headache, run by Kaiser Permanente.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Headache, Photophobia
- What is being tested?
- Avulux Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 13 Dec 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses
This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients
Read the detailed description
Participants:
This study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. Patients who attended the SBC Headache class with a diagnosis of Migraine from the last 12 months will be selected and assigned a number. Random number set will be used to select the 40 patients. Additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. These 40 patients will be randomly assigned to Avulux or Control groups. Each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics.
Design:
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.
Procedure:
Participants will complete a baseline assessment and self-report migraine frequency using the Redcap migraine diary application. Participants will complete testing sessions with both Avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.
- Conditions
- Migraine, Headache, Photophobia
- Being tested
- Avulux Lenses, Placebo Lenses
- Medical subject headings
- Migraine Disorders, Headache, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avulux LensesDevice
Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines
Placebo LensesDevice
Lenses that will look identical to Avulux lenses without the medical benefits
| Study group | Role | What they receive |
|---|---|---|
| Avulux Lenses | Experimental | This group will be receiving migraine treatment using Avulux lenses Receives: Device: Avulux Lenses; Device: Placebo Lenses |
| Placebo Lenses | Placebo comparator | This group will be using identical placebo lenses as treatment Receives: Device: Avulux Lenses; Device: Placebo Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in migraine frequency
headache days per month documented in a headache diary.
Measured: 6 months
Reduction in migraine severity
Severity of headaches on a scale from no, mild, moderate, and sever pain
Measured: 6 months
Secondary outcomes (2)
Improve quality of life
Rating of daily activity performance using Functional Disability Scale (0) No disability-(6) Severe disability
Measured: 6 months
Medication Use
Number of medications used as a form of rescue medication during episode of migraine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start13 Dec 2023 (estimated)
- Primary completion13 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Munish Sharma, OD/MBA, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149000
- Sponsor's protocol ID
- Avulux
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participant data will not be shared
Publications
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.
PubMed 37150129Katz 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.
PubMed 26875996Wilkins 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.
PubMed 2062542Huang 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.
PubMed 21622479
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses
- ClinicalTrials.gov ID
- NCT06149000
- Acronym / sponsor ID
- Avulux
- Conditions
- Migraine, Headache, Photophobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 13 Dec 2023 (estimated)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients
Detailed description
Participants:
This study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. Patients who attended the SBC Headache class with a diagnosis of Migraine from the last 12 months will be selected and assigned a number. Random number set will be used to select the 40 patients. Additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. These 40 patients will be randomly assigned to Avulux or Control groups. Each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics.
Design:
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.
Procedure:
Participants will complete a baseline assessment and self-report migraine frequency using the Redcap migraine diary application. Participants will complete testing sessions with both Avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Avulux Lenses | Experimental | Device: Avulux Lenses, Device: Placebo LensesThis group will be receiving migraine treatment using Avulux lenses |
| Placebo Lenses | Placebo comparator | Device: Avulux Lenses, Device: Placebo LensesThis group will be using identical placebo lenses as treatment |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avulux LensesAvulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines | Device | Avulux Lenses, Placebo Lenses |
| Placebo LensesLenses that will look identical to Avulux lenses without the medical benefits | Device | Avulux Lenses, Placebo Lenses |
Primary outcome
Reduction in migraine frequency
Time frame: 6 months
headache days per month documented in a headache diary.
Reduction in migraine severity
Time frame: 6 months
Severity of headaches on a scale from no, mild, moderate, and sever pain
2 secondary outcomes
Improve quality of life
Time frame: 6 months
Medication Use
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 37150129Posternack 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.
- Background: PubMed 26875996Katz 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.
- Background: PubMed 2062542Wilkins 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.
- Background: PubMed 21622479Huang 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.
- Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical NeuroscienceLink provided by the sponsor.
- Avulux Randomized TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munish Sharma, OD/MBA principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Avulux Lenses in people with Migraine and Headache, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie Aragon, MPH (323-812-5569, Leslie.A.Aragon@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in migraine frequency (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149000, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.