Evaluation of Biomarker Expression in Patients with Migraine
Research type
Research Study
Full title
An Enabling Study to Evaluate Expression of Biomarkers in Participants with Migraine at Baseline and During Migraine Attacks
IRAS ID
332258
Contact name
Minesh Karamshi
Contact email
Sponsor organisation
GSK
Duration of Study in the UK
0 years, 6 months, 12 days
Research summary
Migraine is a common neurological condition affecting almost 15% of the population worldwide that manifest as recurrent attacks of debilitating headache pain lasting 4-72h. Despite available treatments, many people who suffer from migraines still need effective treatment.
Recently, there has been a focus on protein-like molecules present in the brain called neuropeptides. One of these molecules that is present at higher levels in migraine patients and associated with migraine pain, is called Calcitonin gene-related peptide (CGRP). Medications that target this peptide have shown promising results in treatment and preventing migraines. However, 40% of patients do not respond to these medications and there are limitations associated with their use. Therefore, there is still an unmet need to discover medications for the effective treatment of migraine.
In this study, GSK will try to find additional biological molecules related to migraine in the blood and saliva of migraine patients.
The samples will be taken while patients are pain free and during and after a migraine attack. The levels of the molecules and the frequency of migraine attacks will be assessed. It will also assess the relationships between these molecules themselves before, during and after a migraine attack. It will explore the relationship between the severity of migraine pain and the levels of these biomarkers. The blood samples will be taken either in the clinic for baseline samples or at home by the patient with a device called the Tasso+ during and after a migraine attack. The Tasso+ device is a CE (Conformite Europeenne) marked and FDA (Food and Drug Administration) registered product.
Approximately 36 healthy male and female participants, between 18 and 50 years of age, will take part in this study to achieve 30 completers. The expected duration of participation in the study for each individual participant will be approximately 4 months.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0139
Date of REC Opinion
12 Jan 2024
REC opinion
Further Information Favourable Opinion