MigraineNCT04341298
Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
A study testing 11-point pain scale, Headache diary and Avulux® in people with Migraine, run by Avulux, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- 11-point pain scale, Headache diary and Avulux®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Apr 2020to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Endocrinology Research Associates, Inc.
Columbus, Ohio, 43201
Remington-Davis Clinical Research
Columbus, Ohio, 43215
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
About this study
Official title: Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
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.
Read the 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
- Being tested
- 11-point pain scale, Headache diary, Avulux®, Sham Avulux®
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11-point pain scaleOther
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 diaryOther
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
Avulux® device
Sham Avulux®Device
Sham Avulux®
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 11-point pain scale; Other: Headache diary; Device: Sham Avulux® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 2 hours after device application
Secondary outcomes (1)
Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)
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.
Measured: from baseline to four hours after device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start6 Apr 2020
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avulux, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imarc Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341298
- Sponsor's protocol ID
- 20200480
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2020
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37150129
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
- ClinicalTrials.gov ID
- NCT04341298
- Acronym / sponsor ID
- 20200480
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Avulux, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Imarc Research, Inc.
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
| Arm | Type | Receives |
|---|---|---|
| Avulux® device | Experimental | Other: 11-point pain scale, Other: Headache diary, Device: Avulux®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. |
| Control/sham device | Sham comparator | Other: 11-point pain scale, Other: Headache diary, Device: Sham Avulux®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| 11-point pain scaleSubjects 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 | Avulux® device, Control/sham device |
| Headache diarySubjects 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. | Other | Avulux® device, Control/sham device |
| Avulux®Avulux® device | Device | Avulux® device |
| Sham Avulux®Sham Avulux® | Device | Control/sham device |
Primary outcome
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.
1 secondary outcome
Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)
Time frame: from baseline to four hours after device application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11-point pain scale, Headache diary and Avulux® in people with Migraine, run by Avulux, Inc. at 3 sites in United States.
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 14 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache) (time frame: from baseline to 2 hours after device application). 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 NCT04341298, which also lists 1 linked publication.
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 9 Jan 2023.