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Completed

NCT Number: NCT04341298

Use of the 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Institute, Inc., Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Avulux® device

Sham Avulux®

Device

Sham Avulux®

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: from baseline to four hours after device application

    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.

Other outcomes

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

    Time frame: from baseline to 2 hours after device application

    Number of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe (i.e. baseline pain score of 6 or higher) to mild/no pain (defined as a pain score of 3 or less) after an elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

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

    Time frame: baseline to 8 hours after device application

    Number of subjects who require abortive headache medication (e.g. analgesic or triptan) to control their first severe or very severe migraine headache (i.e. baseline pain score of 6 or higher) within 8 hours following application of the device. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

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

    Time frame: 2 hours after device application

    Number of subjects suffering from light sensitivity after elapsed time of 2 hours following application of the device, 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.

  4. Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)

    Time frame: 4 hours after device application

    Number of subjects suffering from light sensitivity after elapsed time of 4 hours following application of the device, 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.

Sponsors and collaborators

Lead sponsor

Avulux, Inc.

Industry

Collaborators

  • Imarc Research, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2020
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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