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| Name | Class |
|---|---|
| Imarc Research, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avulux® device | Experimental | 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. |
|
| Control/sham device | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11-point pain scale | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to 2 hours after device application |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to four hours after device application |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
Headache occurs with at least one of the following symptoms:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States | ||
| Endocrinology Research Associates, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37150129 | Derived | Posternack C, Kupchak P, Capriolo AI, Katz BJ. Targeting the intrinsically photosensitive retinal ganglion cell to reduce headache pain and light sensitivity in migraine: A randomized double-blind trial. J Clin Neurosci. 2023 Jul;113:22-31. doi: 10.1016/j.jocn.2023.04.015. Epub 2023 May 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | from baseline to 2 hours after device application |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Posternack, President | Avulux | 833-288-5890 | cposternack@avulux.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2020 | Apr 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
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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.
| Headache diary | Other | 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® | Device | Avulux® device |
|
| Sham Avulux® | Device | Sham Avulux® |
|
| from baseline to 2 hours after device application |
| 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. | baseline to 8 hours after device application |
| 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. | 2 hours after device application |
| 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. | 4 hours after device application |
| Columbus |
| Ohio |
| 43201 |
| United States |
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | United States |
| BG001 | 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® |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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® |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | from baseline to four hours after device application |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | from baseline to 2 hours after device application |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | baseline to 8 hours after device application |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 2 hours after device application |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 4 hours after device application |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | from baseline to 2 hours after device application |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | from baseline to 4 hours after device application |
|
|
|
|
| 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. | Posted | Number | headaches | from baseline to 2 hours after device application | headaches | headaches |
|
|
|
|
| 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. | Posted | Count of Units | headaches | from baseline to 4 hours after device application | headaches | headaches |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 1 |
| 38 |
| EG001 | 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® | 0 | 40 | 0 | 40 | 0 | 40 |
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Institution can independently publish 12 months from completion of the Study. Investigator shall submit the manuscript of any proposed publication to Sponsor at least 30 days before publication, and Sponsor shall have the right to review and comment upon the manuscript in order to protect Sponsor's Confidential Information. Upon Sponsor's request, publication shall be delayed up to 90 additional days.
| D009422 | Nervous System Diseases |