MigraineNCT04904328
A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
A study testing Lumishade® Active Lens in people with Migraine, run by Mitsui Chemicals, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Lumishade® Active Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- Headache has at least two of the following characteristics:
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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).
- Conditions
- Migraine
- Being tested
- Lumishade® Active Lens, Lumishade® Sham Lens
- Keywords
- Migraine, Aura, Photosensitivity, Wavelength, Lens, Glasses
- Medical subject headings
- Migraine Disorders, Epilepsy, Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumishade® Active LensDevice
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 LensDevice
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.)
| Study group | Role | What they receive |
|---|---|---|
| Lumishade® active lens | Active comparator | Treatment of photosensitive migraine with a Lumishade® active device. Receives: Device: Lumishade® Active Lens |
| Lumishade® sham lens | Sham comparator | Treatment of photosensitive migraine with a Lumishade® sham device. Receives: Device: Lumishade® Sham Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 13 weeks for each patients participation
Secondary outcomes (1)
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
Measured: up to 13 weeks for each patients participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start30 Jun 2021 (estimated)
- Primary completion4 Jan 2022 (estimated)
- Study completion4 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitsui Chemicals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904328
- Sponsor's protocol ID
- LUMIS001
- Other IDs
- ID: 273901
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04904328
- Acronym / sponsor ID
- LUMIS001
- Conditions
- Migraine
- Keywords
- Migraine, Aura, Photosensitivity, Wavelength, Lens, Glasses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Mitsui Chemicals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 4 Jan 2022 (estimated)
- Study completion
- 4 Apr 2022 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumishade® active lens | Active comparator | Device: Lumishade® Active LensTreatment of photosensitive migraine with a Lumishade® active device. |
| Lumishade® sham lens | Sham comparator | Device: Lumishade® Sham LensTreatment of photosensitive migraine with a Lumishade® sham device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumishade® Active LensMigraine 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.) | Device | Lumishade® active lens |
| Lumishade® Sham LensLumishade® 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.) | Device | Lumishade® sham lens |
Primary outcome
Headache Impact Test 6
Time frame: up to 13 weeks for each patients participation
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.
1 secondary outcome
Patient diary
Time frame: up to 13 weeks for each patients participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Lumishade® Active Lens in people with Migraine, run by Mitsui Chemicals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshito Takeuchi (+81-90-4822-4960, Yoshito.Takeuchi@mitsuichemicals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test 6 (time frame: up to 13 weeks for each patients participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.