Back to resultsA Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumishade® Active Lens
Lumishade® Sham Lens
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Aura, Photosensitivity, Wavelength, Lens, Glasses
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients who have a diagnosed neurological disorder that may influence the study according to the investigators
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Lumishade® active lens
Lumishade® sham lens
Arm Description
Treatment of photosensitive migraine with a Lumishade® active device.
Treatment of photosensitive migraine with a Lumishade® sham device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient diary
A headache diary. A headache diary serves to:
Monitor the frequency, duration and severity of your headaches over time
Identify patterns that may help determine triggers and improve treatment
Track medication use and response
Maintain long term records of what has worked and what has not
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904328
Brief Title
A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
Official Title
A Proof of Concept Clinical Investigation Designed to Evaluate the Performance of Lumishade® Lens With Frame in Alleviating the Symptoms of Photosensitive Migraine.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
January 4, 2022 (Anticipated)
Study Completion Date
April 4, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsui Chemicals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Patients wear sham glasses for 4 weeks
Patients have 1 week's washout
Patients wear active glasses for 4 weeks
Group 2
Patients wear active glasses for 4 weeks
Patients have 1 week's washout
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Aura, Photosensitivity, Wavelength, Lens, Glasses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lumishade® active lens
Arm Type
Active Comparator
Arm Description
Treatment of photosensitive migraine with a Lumishade® active device.
Arm Title
Lumishade® sham lens
Arm Type
Sham Comparator
Arm Description
Treatment of photosensitive migraine with a Lumishade® sham device.
Intervention Type
Device
Intervention Name(s)
Lumishade® Active Lens
Intervention Description
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
Intervention Name(s)
Lumishade® Sham Lens
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Headache Impact Test 6
Description
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.
Time Frame
up to 13 weeks for each patients participation
Secondary Outcome Measure Information:
Title
Patient diary
Description
A headache diary. A headache diary serves to:
Monitor the frequency, duration and severity of your headaches over time
Identify patterns that may help determine triggers and improve treatment
Track medication use and response
Maintain long term records of what has worked and what has not
Time Frame
up to 13 weeks for each patients participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Patients who have a diagnosed neurological disorder that may influence the study according to the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshito Takeuchi
Phone
+81-90-4822-4960
Email
Yoshito.Takeuchi@mitsuichemicals.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hironori Kuboi
Phone
+81-3-6253-3167
Email
Hironori.Kuboi@mitsuichemicals.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
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