Clinical trial NCT03902496: Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.
Official title: Optical Treatment of Migraines Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Avulux, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Headache Impact Test (HIT-6) total score
timeFrame: Three-week
Secondary outcomes:
measure: Number and Severity of Headache Days
timeFrame: Three-week
Other outcomes:
measure: Proportion of subjects who were able to move out of the "very severe impact" category of the HIT-6 during the 3-week intervention
timeFrame: Three-week
measure: Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention
timeFrame: Three-week
measure: Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention
timeFrame: Three-week
measure: Proportion of days with light sensitivity over the 3-week intervention
timeFrame: Three-week
measure: Average Number of Hours Slept over the 3-week intervention
timeFrame: Three-week
Locations:
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
Study officials:
References: