Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01942486
Other study ID # IRB_00065178
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date April 2018

Study information

Verified date November 2022
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 35
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria: 1. Must be diagnosed with migraine with aura or migraine without aura 2. Must have at least 10 headache days per month Exclusion Criteria: 1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity 2. Pregnant 3. Unwilling or unable in the judgment of the investigator to complete the study 4. Unavailable for any of the study visits 5. Light sensitive conditions: meningitis, iritis, blepharospasm, albinism 6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy 7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs 8. Best corrected visual acuity less than 20/40 in either eye

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Investigational Coating


Locations

Country Name City State
United States Moran Eye Center Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
University of Utah Primary Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT01432379 - BOTOX® Prophylaxis in Patients With Chronic Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05048914 - Migraine Abortive Treatment
Completed NCT03662295 - Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Completed NCT02766517 - Biomarker Study in Participants With Migraine Early Phase 1
Completed NCT00963937 - Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents Phase 3
Not yet recruiting NCT03632928 - Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Completed NCT02559895 - A Multicenter Assessment of ALD403 in Frequent Episodic Migraine Phase 3
Completed NCT01435941 - Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine N/A
Completed NCT00743015 - Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks Phase 1
Completed NCT01376141 - Drug Use Investigation for IMIGRAN Tablet N/A
Completed NCT02183688 - Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients Phase 3
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Completed NCT03588364 - The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine N/A
Completed NCT04091321 - Association Between Chronic Headache and Back Pain With Childbirth
Completed NCT00385008 - TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine Phase 3
Active, not recruiting NCT05888298 - Proximal and Distal Approach GON RFT in Migraine N/A
Completed NCT03435185 - Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients N/A
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT02565186 - An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine Phase 3