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

• ClinicalTrials.gov Identifier: NCT03902496
• Recruitment Status: Completed
• First Posted: April 4, 2019
• Last Update Posted: July 5, 2019
• Sponsor: Avulux, Inc.
• Information provided by (Responsible Party): Avulux, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine	Other: HIT-6 Questionnaire; Device: Avulux Spectacles; Device: Sham Spectacles	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A total of 50 subjects will be randomized into one of two treatment groups in a one-to-one ratio. After three weeks, and following a one-week washout period, subjects will be given spectacles from the other treatment group
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: The active and sham lenses will have tints calibrated such that the optical density, that is the overall "darkness" of all study lenses, will be the same. All study lenses will appear to have the same overall light-blocking effect to study subjects.
• Primary Purpose: Treatment
• Official Title: Optical Treatment of Migraines Clinical Study
• Actual Study Start Date: March 18, 2019
• Actual Primary Completion Date: May 17, 2019
• Actual Study Completion Date: May 17, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: HIT-6 Questionnaire; Headache Impact Test; Device: Avulux Spectacles; Avulux™ Optical Filter in the Form of Spectacle Lenses
Sham Comparator: 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.	Other: HIT-6 Questionnaire; Headache Impact Test; Device: Sham Spectacles; Sham

Outcome Measures

Primary Outcome Measures :

1. Headache Impact Test (HIT-6) total score [ Time Frame: 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 :

1. Number and Severity of Headache Days [ Time Frame: 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.

Other Outcome Measures:

1. Proportion of subjects who were able to move out of the "very severe impact" category of the HIT-6 during the 3-week intervention [ Time Frame: Three-week ]
   Compare initial vs. final HIT-6 scores for each treatment period
2. Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention [ Time Frame: Three-week ]
   Compare initial vs. final HIT-6 scores for each treatment period
3. Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention [ Time Frame: Three-week ]
   Compare diaries for treatment vs. control periods to determine proportion of headaches resolved by device vs. device plus medication
4. Proportion of days with light sensitivity over the 3-week intervention [ Time Frame: Three-week ]
   Compare diaries for treatment vs. control periods to determine differences in days with light sensitivity.
5. Average Number of Hours Slept over the 3-week intervention [ Time Frame: Three-week ]
   Compare diaries for treatment vs. control periods to determine whether a significant difference exists in number of hours slept between treatment groups.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Ohio

Remington-Davis Clinical Research

Columbus, Ohio, United States, 43215

Sponsors and Collaborators

Avulux, Inc.

  Study Documents (Full-Text)

Documents provided by Avulux, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] February 28, 2019

Informed Consent Form  [PDF] March 14, 2019

More Information

• Responsible Party: Avulux, Inc.
• ClinicalTrials.gov Identifier: NCT03902496
• Other Study ID Numbers: 20190592
• First Posted: April 4, 2019
• Last Update Posted: July 5, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

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