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

Not Applicable

Completed

Conditions: Migraine

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

Registration Number: NCT04341298

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avulux® device	Headache diary	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.
Avulux® device	11-point pain scale	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	11-point pain scale	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	Headache diary	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.
Avulux® 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 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.

Primary Outcome Measures

Name	Time	Method
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)	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 Outcome Measures

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

Trial Locations

Locations (3): Endocrinology Research Associates, Inc.
🇺🇸
Columbus, Ohio, United States
Remington-Davis Clinical Research
🇺🇸
Columbus, Ohio, United States
Clinical Research Institute, Inc.
🇺🇸
Minneapolis, Minnesota, United States