An interventional study of Investigational Coating in Migraine Disorders and Photophobia, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Investigational Coating
HIT-6 Score
The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
Time frame: 12 weeks
| Milestone | Investigational Coating |
|---|---|
| Started | 35 |
| Completed | 8 |
| Not completed | 27 |
| Withdrew: Lost to follow-up | 27 |
The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
| units on a scale | Investigational Coating |
|---|---|
| HIT-6 Score | 62.3 ± 4.8 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Coating | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Categorical(Participants) | Investigational Coating |
|---|---|
| <=18 years | 35 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Investigational Coating |
|---|---|
| Mean | 13 ± 3.5 |
| Sex: Female, Male(Participants) | Investigational Coating |
|---|---|
| Female | 20 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | Investigational Coating |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 35 |
| Region of Enrollment(participants) | Investigational Coating |
|---|---|
| United States | 35 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Jan 2014, a primary completion of Apr 2018 and a completion of Apr 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2020, 1 year 11 months after primary completion.
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This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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