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Completed

NCT Number: NCT03902496

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Remington-Davis Clinical Research

Columbus, Ohio, 43215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is 18 years or older
  • Patient is willing and able to provide written informed consent
  • Patient is willing and able to complete all scheduled study visits
  • Diagnosis of migraine, based on the following primary headache characteristics:
  • At least 5 attacks fulfilling criteria b-d:
  • 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 (eg, walking or climbing stairs)
  • During headache at least one of the following:
  • nausea and/or vomiting
  • photophobia and phonophobia
  • Not attributed to another disorder

Exclusion criteria

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

Treatment and study plan

HIT-6 Questionnaire

Other

Headache Impact Test

Avulux Spectacles

Device

Avulux™ Optical Filter in the Form of Spectacle Lenses

Sham Spectacles

Device

Sham

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Avulux, Inc.

Industry

Registry information

Official study title

Optical Treatment of Migraines Clinical Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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