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Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

NCT04341298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-01-09

Study results available
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Summary

The purpose of this research is to assess how well the Avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.

Conditions

Interventions

OTHER

11-point pain scale

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.

OTHER

Headache diary

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.

DEVICE

Avulux®

Avulux® device

DEVICE

Sham Avulux®

Sham Avulux®

Sponsors & Collaborators

  • Imarc Research, Inc.

    collaborator INDUSTRY

  • Avulux, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-06
Primary Completion
2020-08-26
Completion
2020-08-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341298 on ClinicalTrials.gov