A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.

NCT04904328 | Unknown DMC

• 2 other identifiers: LUMIS001ID: 273901
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

This proof of concept clinical study will investigate the efficacy of active lens with frame in alleviating the symptoms of migraine which are caused by photosensitivity. The spectacles cut out blue light wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring.

Conditions

Migraine

Keywords

Migraine; Aura; Photosensitivity; Wavelength; Lens; Glasses

Outcome Measures

Primary Outcomes (1)

• Headache Impact Test 6

  The primary endpoint is the change in Headache Impact Test (HIT-6) score from end of run-in (Baseline) to end of treatment period following 4 weeks of treatment. The HIT 6 questionnaire is a licensed questionnaire with standardised calculations to assess the responses to the questions in the questionnaire.

  up to 13 weeks for each patients participation

Secondary Outcomes (1)

• Patient diary

  up to 13 weeks for each patients participation

Study Arms (2)

Lumishade® active lens

ACTIVE COMPARATOR

Treatment of photosensitive migraine with a Lumishade® active device.

Device: Lumishade® Active Lens

Lumishade® sham lens

SHAM COMPARATOR

Treatment of photosensitive migraine with a Lumishade® sham device.

Device: Lumishade® Sham Lens

Interventions

Lumishade® Active Lens DEVICE

Migraine episodes are often triggered or exacerbated by environmental factors, particularly light. Active lens has been designed by blocking particular range of wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring. (Note, we are reluctant to write any further information around the devices on this public record while the study is active to ensure we maintain the blind of the trial.)

Lumishade® active lens

Lumishade® Sham Lens DEVICE

Lumishade® Sham lens has been designed as inactive and not blocking particular range of wavelength. Thus, it will not alleviate or prevent symptoms of migraine. (Note, we are reluctant to write any further information around the devices on this public record while the study is active to ensure we maintain the blind of the trial.)

Lumishade® sham lens

Eligibility Criteria

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

You may qualify if:

• Over 18 years old
• Diagnosis of migraine before the age of 50, confirmed though screening consultation with the patient
• Willing and able to provide written informed consent
• Willing to comply with study assessment schedule and patient diary entry
• Diagnosis of migraine, with or without aura based on the following primary headache characteristics (based on the Revised International Headache Society criteria for migraine headache)
• 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:
• i. unilateral location ii. pulsating quality iii. moderate or severe pain intensity iv. aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) d. During headache at least one of the following: i. nausea and/or vomiting ii. photophobia and phonophobia e. Not attributed to another disorder
• Migraine associated with photophobia i.e. either photic hypersensitivity or photic allodynia or inter-ictal photophobia or migraine triggered by light according to patient or a combination of these 4 factors
• No expected changes of headache preventative medications after enrolment

You may not qualify if:

• Patients with other light sensitive conditions, such as iritis or retinal disease.
• Patients who have less than 4 headache days per month
• Patients who have daily headaches.
• Pregnant or nursing
• History of cluster headache or hemiplegic migraine
• Evidence of seizure or major psychiatric disorder
• Score of 19 or higher on the BDI
• Active chronic pain syndrome
• Cardiac or hepatic disease
• Have taken any investigational medication within 12 weeks before randomization, or are scheduled to receive an investigational drug
• Have received Botox injections for any purpose in the head or face region within 3 months of trial onset or scheduled to receive such treatment during the trial
• Medication overuse as per the revised ICHD-3 IHS criteria
• Medications that can affect light perception like ethambutol, hydroxychloroquine or amiodarone or any other according to the opinion of the investigator
• Patients requiring prescription/reading glasses
• Patients who have not responded to three or more migraine preventive drugs

Sponsors & Collaborators

• Mitsui Chemicals, Inc.: lead

MeSH Terms

Conditions

Migraine Disorders; Epilepsy; Photosensitivity Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yoshito Takeuchi

CONTACT

+81-90-4822-4960; Yoshito.Takeuchi@mitsuichemicals.com

Hironori Kuboi

CONTACT

+81-3-6253-3167; Hironori.Kuboi@mitsuichemicals.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: June 30, 2021
• Primary Completion: January 4, 2022
• Study Completion: April 4, 2022
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share