Clinical trial NCT04341298: Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Official title: Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Avulux, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Imarc Research, Inc.
First posted: 2020-04-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
timeFrame: from baseline to 2 hours after device application
Secondary outcomes:
measure: Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)
timeFrame: from baseline to four hours after device application
Other outcomes:
measure: Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)
timeFrame: from baseline to 2 hours after device application
measure: Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)
timeFrame: baseline to 8 hours after device application
measure: Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)
timeFrame: 2 hours after device application
measure: Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)
timeFrame: 4 hours after device application
Locations:
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Columbus
country: United States
facility: Endocrinology Research Associates, Inc.
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
Study officials:
References: