Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.
NCT ID: NCT03902496
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2019-03-18
2019-05-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
NCT04341298
Migraine Headache Mitigation Utilizing Avulux
NCT06149000
Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
NCT03398668
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine
NCT01314651
Neurolens Headache Study
NCT05070767
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Avulux™ consists of a pair of optical filters in the form of spectacle lenses, provided in standard spectacle frames or as clip-on units, coated with a thin film 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Avulux Spectacles
Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.
HIT-6 Questionnaire
Headache Impact Test
Avulux Spectacles
Avulux™ Optical Filter in the Form of Spectacle Lenses
Sham Spectacles
Subjects will be instructed to use the spectacles for three weeks. They will be instructed to put the spectacles on at the first signs or symptoms of their migraine attacks. This could be their usual aura, or the first signs of their headache commencing, and to keep the spectacles on until their headache has resolved.
HIT-6 Questionnaire
Headache Impact Test
Sham Spectacles
Sham
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HIT-6 Questionnaire
Headache Impact Test
Avulux Spectacles
Avulux™ Optical Filter in the Form of Spectacle Lenses
Sham Spectacles
Sham
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient is willing and able to provide written informed consent
3. Patient is willing and able to complete all scheduled study visits
4. Diagnosis of migraine, based on the following primary headache characteristics:
1. At least 5 attacks fulfilling criteria b-d:
2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
3. 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 (eg, walking or climbing stairs)
4. During headache at least one of the following:
* nausea and/or vomiting
* photophobia and phonophobia
5. Not attributed to another disorder
Exclusion Criteria
2. Patients who have less than 4 headache days per month
3. Patients who have chronic daily headaches.
4. Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avulux, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Remington-Davis Clinical Research
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20190592
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.