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

Avulux

Status: Completed

Conditions: Migraine

Treatments: Other: Headache diary; Device: Avulux®; Device: Sham Avulux®; Other: 11-point pain scale

Study type: Interventional

Funder types: Industry

Identifiers

NCT04341298

20200480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

Avulux® device

Experimental group

Description:

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.

Treatment:

Other: 11-point pain scale

Device: Avulux®

Other: Headache diary

Control/sham device

Sham Comparator group

Description:

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.

Treatment:

Other: 11-point pain scale

Device: Sham Avulux®

Other: Headache diary