Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Other: HIT-6 Questionnaire; Device: Avulux Spectacles; Device: Sham Spectacles

• Registration Number: NCT03902496
• Lead Sponsor: Avulux, Inc.

Brief Summary

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 Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.

Detailed Description

Avulux™ is intended to decrease the impact of headache and migraine on normal daily life and the ability to function, and reduce the frequency and severity of headache, in adult patients diagnosed with episodic migraine headache or chronic migraine.

Avulux™ consists of a pair of optical filters in the form of spectacle lenses, provided in standard spectacle frames or as clip-on units, coated with a thin film 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.

Study Timeline

• Study Start: 2019-03-18
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Primary Completion: 2019-05-17
• Study Completion: 2019-05-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient is 18 years or older

2. Patient is willing and able to provide written informed consent

3. Patient is willing and able to complete all scheduled study visits

4. Diagnosis of migraine, based on the following primary headache characteristics:

   1. At least 5 attacks fulfilling criteria b-d:

   2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

   3. 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 (eg, walking or climbing stairs)

   4. During headache at least one of the following:

      • nausea and/or vomiting
      • photophobia and phonophobia

   5. Not attributed to another disorder

Exclusion Criteria

1. Patients with other light sensitive conditions, such as iritis.
2. Patients who have less than 4 headache days per month
3. Patients who have chronic daily headaches.
4. Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Spectacles	HIT-6 Questionnaire	Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.
Avulux Spectacles	HIT-6 Questionnaire	Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.
Avulux Spectacles	Avulux Spectacles	Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.
Sham Spectacles	Sham Spectacles	Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.

Primary Outcome Measures

Name	Time	Method
Headache Impact Test (HIT-6) total score	Three-week	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 Headache Impact Test (HIT-6) scores at three weeks when compared to a control/sham device. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact.

Secondary Outcome Measures

Name	Time	Method
Number and Severity of Headache Days	Three-week	To measure effects on the number and severity of headaches, we will use the subjects' daily diaries to count the number of days with headache that either a) made activity difficult, b) caused activity changes, or c) caused patient to go to bed. We will then compare the proportion of days with headaches that met one of these criteria for the 4-week baseline period and the 3-week intervention.

Trial Locations

Locations (1)

Remington-Davis Clinical Research; 🇺🇸 Columbus, Ohio, United States