A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.

NCT ID: NCT04904328

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-04-04

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.

Detailed Description

Patients will be randomised to one of two groups:

Group 1

1. Patients wear sham glasses for 4 weeks

2. Patients have 1 week's washout

3. Patients wear active glasses for 4 weeks

Group 2

4. Patients wear active glasses for 4 weeks

5. Patients have 1 week's washout

6. Patients wear sham glasses for 4 weeks

The study will aim to determine whether wearing the active lens successfully reduces the symptoms of migraine, compared to wearing sham lens.

Assuming a fairly conservative SD in the primary endpoint of 8 points, a total of 56 participants would be required to have 90% power to detect a minimum clinically significant difference of 5 points in a two-sample t-test. Allowing for a 20% drop-out rate, 70 participants would need to be recruited.

Patients will be in the trial for a total of 13 weeks (4 week run-in, two 4 week periods, with 1 week washout in between).

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumishade® active lens

Treatment of photosensitive migraine with a Lumishade® active device.

Group Type: ACTIVE_COMPARATOR

Lumishade® Active Lens

Intervention Type: 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® sham lens

Treatment of photosensitive migraine with a Lumishade® sham device.

Group Type: SHAM_COMPARATOR

Lumishade® Sham Lens

Intervention Type: 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.)

Interventions

Lumishade® Active Lens

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.)

Intervention Type: DEVICE

Lumishade® Sham Lens

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.)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Over 18 years old

2. Diagnosis of migraine before the age of 50, confirmed though screening consultation with the patient

3. Willing and able to provide written informed consent

4. Willing to comply with study assessment schedule and patient diary entry

5. 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)

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:

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

6. 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

7. No expected changes of headache preventative medications after enrolment

Exclusion Criteria

1. Patients with other light sensitive conditions, such as iritis or retinal disease.

2. Patients who have less than 4 headache days per month

3. Patients who have daily headaches.

4. Pregnant or nursing

5. History of cluster headache or hemiplegic migraine

6. Evidence of seizure or major psychiatric disorder

7. Score of 19 or higher on the BDI

8. Active chronic pain syndrome

9. Cardiac or hepatic disease

10. Have taken any investigational medication within 12 weeks before randomization, or are scheduled to receive an investigational drug

11. 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

12. Medication overuse as per the revised ICHD-3 IHS criteria

13. Medications that can affect light perception like ethambutol, hydroxychloroquine or amiodarone or any other according to the opinion of the investigator

14. Patients requiring prescription/reading glasses

15. Patients who have not responded to three or more migraine preventive drugs

16. Patients who have a diagnosed neurological disorder that may influence the study according to the investigators

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitsui Chemicals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yoshito Takeuchi

Role: CONTACT

Yoshito.Takeuchi@mitsuichemicals.com

+81-90-4822-4960

Hironori Kuboi

Role: CONTACT

Hironori.Kuboi@mitsuichemicals.com

+81-3-6253-3167

Other Identifiers

ID: 273901

Identifier Type: OTHER

Identifier Source: secondary_id

LUMIS001

Identifier Type: -

Identifier Source: org_study_id