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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902496
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902496


Locations
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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.:
Informed Consent Form  [PDF] March 14, 2019


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Responsible Party: Avulux, Inc.
ClinicalTrials.gov Identifier: NCT03902496    
Other Study ID Numbers: 20190592
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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