Optical Treatment of Migraines Using the Avulux™ Optical Filter in the Form of Spectacle Lenses.

NCT03902496 | Completed FDA Device

• 1 other identifier: 20190592
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6TM) scores at three weeks when compared to a control/sham device.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Headache Impact Test (HIT-6) total score

  The primary objective of this study is to evaluate the efficacy of the Avulux device in reducing the impact of migraine headaches as measured by improvement in Headache Impact Test (HIT-6) scores at three weeks when compared to a control/sham device. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact.

  Three-week

Secondary Outcomes (1)

• Number and Severity of Headache Days

  Three-week

Other Outcomes (5)

• Proportion of subjects who were able to move out of the "very severe impact" category of the HIT-6 during the 3-week intervention

  Three-week

• Proportion of patients who experienced at least a 5-point improvement in their HIT-6 score during the 3-week intervention

  Three-week

• Proportion of days with headaches which lead to use of medications to control the headache over the 3-week intervention

  Three-week

Study Arms (2)

Avulux Spectacles

EXPERIMENTAL

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.

Other: HIT-6 Questionnaire; Device: Avulux Spectacles

Sham Spectacles

SHAM COMPARATOR

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.

Other: HIT-6 Questionnaire; Device: Sham Spectacles

Interventions

HIT-6 Questionnaire OTHER

Headache Impact Test

Avulux Spectacles; Sham Spectacles

Avulux Spectacles DEVICE

Avulux™ Optical Filter in the Form of Spectacle Lenses

Avulux Spectacles

Sham Spectacles DEVICE

Sham

Sham Spectacles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years or older
• Patient is willing and able to provide written informed consent
• Patient is willing and able to complete all scheduled study visits
• Diagnosis of migraine, based on the following primary headache characteristics:
• At least 5 attacks fulfilling criteria b-d:
• 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 (eg, walking or climbing stairs)
• During headache at least one of the following:
• nausea and/or vomiting
• photophobia and phonophobia
• Not attributed to another disorder

You may not qualify if:

• Patients with other light sensitive conditions, such as iritis.
• Patients who have less than 4 headache days per month
• Patients who have chronic daily headaches.
• Patients who have had any change in their migraine treatment within the 4 weeks prior to the trial onset.

Sponsors & Collaborators

• Avulux, Inc.: lead

Study Sites (1)

Remington-Davis Clinical Research

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The active and sham lenses will have tints calibrated such that the optical density, that is the overall "darkness" of all study lenses, will be the same. All study lenses will appear to have the same overall light-blocking effect to study subjects.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 50 subjects will be randomized into one of two treatment groups in a one-to-one ratio. After three weeks, and following a one-week washout period, subjects will be given spectacles from the other treatment group

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: March 18, 2019
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)