- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04341298
Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Minnesota
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Minneapolis, Minnesota, United States, 55402
- Clinical Research Institute, Inc.
-
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Ohio
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Columbus, Ohio, United States, 43201
- Endocrinology Research Associates, Inc.
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Columbus, Ohio, United States, 43215
- Remington-Davis Clinical Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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
|
Sham Comparator: 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.
|
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.
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®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
Time Frame: 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.
|
from baseline to 2 hours after device application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)
Time Frame: 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.
|
from baseline to four hours after device application
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)
Time Frame: 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.
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from baseline to 2 hours after device application
|
Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)
Time Frame: baseline to 8 hours after device application
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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.
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baseline to 8 hours after device application
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Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)
Time Frame: 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.
|
2 hours after device application
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Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)
Time Frame: 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.
|
4 hours after device application
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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