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

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ClinicalTrials.gov Identifier: NCT04341298
Recruitment Status : Completed
First Posted : April 10, 2020
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Imarc Research, Inc.
Information provided by (Responsible Party):
Avulux, Inc.

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.

Condition or disease Intervention/treatment Phase
Migraine Other: 11-point pain scale Other: Headache diary Device: Avulux® Device: Sham Avulux® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : August 26, 2020
Actual Study Completion Date : August 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: 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.
Other: 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.

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.

Device: Avulux®
Avulux® device

Sham Comparator: 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.
Other: 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.

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.

Device: Sham Avulux®
Sham Avulux®




Primary Outcome Measures :
  1. 11-point pain scale total score at two hours [ Time Frame: 2 hours ]
    The primary objective of this study is to evaluate the efficacy of the Avulux® device in reducing the impact of migraine headaches, as measured by improvement in an 11-point pain scale after 2 hours of device application, when compared to a control/sham device.


Secondary Outcome Measures :
  1. 11-point pain scale total score at four hours [ Time Frame: four hours ]
    The secondary objective of this study is to evaluate the efficacy of the Avulux® device in reducing the impact of migraine headaches, as measured by improvement in an 11-point pain scale after 4 hours of device application, when compared to a control/sham device.


Other Outcome Measures:
  1. Quantifiable improvement in overall migraine impact [ Time Frame: 2 hours ]
    To compare the proportion of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe to mild/no pain (defined as a pain score of 3 or less), when using the Avulux® device vs. control/sham device after an elapsed time of 2 hours following application of the device.

  2. Proportion of subjects who require the use of abortive medications when using the Avulux® device vs. the control/sham device. [ Time Frame: 8 hours ]
    To compare the proportion of subjects who require abortive medication to control their first severe or very severe migraine headache within 8 hours following application of the Avulux® device vs. control/sham device.

  3. Proportion of subjects suffering from light sensitivity as a result of their migraine headache [ Time Frame: 2 hours and 4 hours ]
    To compare the proportion of subjects suffering from light sensitivity after elapsed times of 2 hours and 4 hours as a result of their migraine headache when using the Avulux® device vs. control/sham device.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341298


Locations
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United States, Minnesota
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States, 55402
United States, Ohio
Endocrinology Research Associates, Inc.
Columbus, Ohio, United States, 43201
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Avulux, Inc.
Imarc Research, Inc.
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Responsible Party: Avulux, Inc.
ClinicalTrials.gov Identifier: NCT04341298    
Other Study ID Numbers: 20200480
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations