Migraine
Conditions
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.
Interventions
OTHERHIT-6 Questionnaire
Headache Impact Test
DEVICEAvulux Spectacles
Avulux™ Optical Filter in the Form of Spectacle Lenses
DEVICESham Spectacles
Sham
Sponsors
Avulux, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Impact Test (HIT-6) total score | 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
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Headache Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention | Three-week | Compare diaries for treatment vs. control periods to determine proportion of headaches resolved by device vs. device plus medication |
| Proportion of subjects who were able to move out of the very severe impact category of the HIT-6 during the 3-week intervention | Three-week | Compare initial vs. final HIT-6 scores for each treatment period |
| Average Number of Hours Slept over the 3-week intervention | Three-week | Compare diaries for treatment vs. control periods to determine whether a significant difference exists in number of hours slept between treatment groups. |
| Proportion of days with light sensitivity over the 3-week intervention | Three-week | Compare diaries for treatment vs. control periods to determine differences in days with light sensitivity. |
| Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention | Three-week | Compare initial vs. final HIT-6 scores for each treatment period |
Countries
United States
Outcome results
None listed