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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
11-point pain scale
Headache diary
Avulux®
Sham Avulux®
Sponsored by
Avulux, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Clinical Research Institute, Inc.
  • Endocrinology Research Associates, Inc.
  • Remington-Davis Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Avulux® device

Control/sham device

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
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

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

Full Information

First Posted
April 8, 2020
Last Updated
April 11, 2022
Sponsor
Avulux, Inc.
Collaborators
Imarc Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04341298
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
August 26, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avulux, Inc.
Collaborators
Imarc Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avulux® device
Arm Type
Experimental
Arm 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.
Arm Title
Control/sham device
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
11-point pain scale
Intervention Description
Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Intervention Type
Other
Intervention Name(s)
Headache diary
Intervention Description
Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.
Intervention Type
Device
Intervention Name(s)
Avulux®
Intervention Description
Avulux® device
Intervention Type
Device
Intervention Name(s)
Sham Avulux®
Intervention Description
Sham Avulux®
Primary Outcome Measure Information:
Title
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
Description
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.
Time Frame
from baseline to 2 hours after device application
Secondary Outcome Measure Information:
Title
Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)
Description
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.
Time Frame
from baseline to four hours after device application
Other Pre-specified Outcome Measures:
Title
Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)
Description
Number of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe (i.e. baseline pain score of 6 or higher) to mild/no pain (defined as a pain score of 3 or less) after an elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame
from baseline to 2 hours after device application
Title
Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)
Description
Number of subjects who require abortive headache medication (e.g. analgesic or triptan) to control their first severe or very severe migraine headache (i.e. baseline pain score of 6 or higher) within 8 hours following application of the device. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame
baseline to 8 hours after device application
Title
Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)
Description
Number of subjects suffering from light sensitivity after elapsed time of 2 hours following application of the device, 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.
Time Frame
2 hours after device application
Title
Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)
Description
Number of subjects suffering from light sensitivity after elapsed time of 4 hours following application of the device, 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.
Time Frame
4 hours after device application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Endocrinology Research Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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