Migraine
Conditions
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.
Interventions
OTHER11-point pain scale
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.
OTHERHeadache diary
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.
DEVICEAvulux®
Avulux® device
DEVICESham Avulux®
Sham Avulux®
Sponsors
Imarc Research, Inc.
Avulux, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Intervention model description
A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 11-point Pain Scale Score After Two Hours (First Severe Headache) | from baseline to 2 hours after device application | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in 11-point Pain Scale Score After Four Hours (First Severe Headache) | from baseline to four hours after device application | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache) | from baseline to 2 hours after device application | 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. |
| Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache) | baseline to 8 hours after device application | 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. |
| Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache) | 2 hours after device application | 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. |
| Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache) | 4 hours after device application | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avulux® Device 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.
11-point pain scale: 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.
Headache diary: 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.
Avulux®: Avulux® device | 38 |
| Control/Sham Device 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.
11-point pain scale: 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.
Headache diary: 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.
Sham Avulux®: Sham Avulux® | 40 |
| Total | 78 |
Baseline characteristics
| Characteristic | Avulux® Device | Control/Sham Device | Total |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 13.3 | 44.3 years STANDARD_DEVIATION 13.9 | 46.2 years STANDARD_DEVIATION 13.7 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African-American | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 31 Participants | 34 Participants | 65 Participants |
| Region of Enrollment United States | 38 Participants | 40 Participants | 78 Participants |
| Sex: Female, Male Female | 31 Participants | 33 Participants | 64 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 1 / 38 | 0 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 |
Outcome results
Primary
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.
Time frame: from baseline to 2 hours after device application
Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 2 hours after device application for their first severe headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avulux® Device | Change in 11-point Pain Scale Score After Two Hours (First Severe Headache) | -1.42 score on a scale | Standard Deviation 1.9 |
| Control/Sham Device | Change in 11-point Pain Scale Score After Two Hours (First Severe Headache) | -1.14 score on a scale | Standard Deviation 1.43 |
p-value: 0.65Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: from baseline to four hours after device application
Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 4 hours after device application for their first severe headache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avulux® Device | Change in 11-point Pain Scale Score After Four Hours (First Severe Headache) | -2.67 score on a scale | Standard Deviation 2.67 |
| Control/Sham Device | Change in 11-point Pain Scale Score After Four Hours (First Severe Headache) | -2.80 score on a scale | Standard Deviation 2.66 |
p-value: 0.87t-test, 2 sided
Post Hoc
Change in 11-point Pain Scale Score After Four Hours (All Headaches)
Change in migraine pain from baseline to 4 hours after device application, based on all migraine headaches experienced by a study subjects (i.e. baseline pain score of 2 or greater). 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 4 hours after device application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avulux® Device | Change in 11-point Pain Scale Score After Four Hours (All Headaches) | -3.46 score on a scale | Standard Deviation 2.87 |
| Control/Sham Device | Change in 11-point Pain Scale Score After Four Hours (All Headaches) | -2.10 score on a scale | Standard Deviation 2.8 |
Comparison: Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.p-value: 0.019Mixed Models Analysis
Post Hoc
Change in 11-point Pain Scale Score After Two Hours (All Headaches)
Change in migraine pain from baseline to 2 hours after device application, based on all migraine headaches experienced by a study subjects (i.e. baseline pain score of 2 or greater). 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avulux® Device | Change in 11-point Pain Scale Score After Two Hours (All Headaches) | -1.91 score on a scale | Standard Deviation 2.13 |
| Control/Sham Device | Change in 11-point Pain Scale Score After Two Hours (All Headaches) | -1.05 score on a scale | Standard Deviation 1.82 |
Comparison: Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.p-value: 0.021Mixed Models Analysis
Post Hoc
Number of Headaches With Associated Light Sensitivity After 2 Hours (All Headaches)
Number of headaches with associated light sensitivity after elapsed time of 2 hours following application of the device, based on all migraine headaches experienced by study subjects (i.e. baseline pain score of 2 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avulux® Device | Number of Headaches With Associated Light Sensitivity After 2 Hours (All Headaches) | 31 headaches |
| Control/Sham Device | Number of Headaches With Associated Light Sensitivity After 2 Hours (All Headaches) | 63 headaches |
p-value: 0.028Mixed Models Analysis
Post Hoc
Number of Headaches With Associated Light Sensitivity After 4 Hours (All Headaches)
Number of headaches with associated light sensitivity after elapsed time of 4 hours following application of the device, based on all migraine headaches experienced by study subjects (i.e. baseline pain score of 2 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 4 hours after device application
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Avulux® Device | Number of Headaches With Associated Light Sensitivity After 4 Hours (All Headaches) | 24 headaches |
| Control/Sham Device | Number of Headaches With Associated Light Sensitivity After 4 Hours (All Headaches) | 34 headaches |
Comparison: Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.p-value: 0.46Mixed Models Analysis
Other Pre-specified
Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)
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
Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether light sensitivity was experienced two hours after device application for their first severe headache.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avulux® Device | Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache) | 9 Participants |
| Control/Sham Device | Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache) | 16 Participants |
Comparison: Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.p-value: 0.19Mantel Haenszel
Other Pre-specified
Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)
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
Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether light sensitivity was experienced four hours after device application for their first severe headache.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avulux® Device | Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache) | 7 Participants |
| Control/Sham Device | Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache) | 10 Participants |
Comparison: Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.p-value: 1Mantel Haenszel
Other Pre-specified
Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)
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
Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether abortive medications were used within 8 hours of device application for their first severe headache.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avulux® Device | Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache) | 11 Participants |
| Control/Sham Device | Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache) | 11 Participants |
Comparison: Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.p-value: 0.59Mantel Haenszel
Other Pre-specified
Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)
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
Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 2 hours after device application for their first severe headache.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avulux® Device | Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache) | 2 Participants |
| Control/Sham Device | Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache) | 4 Participants |
Comparison: Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.p-value: 0.66Mantel Haenszel