Status:
UNKNOWN
A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
Lead Sponsor:
Mitsui Chemicals, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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. Patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04904328
Start Date
June 30 2021
End Date
April 4 2022
Last Update
May 27 2021
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