Migraine
Conditions
Brief summary
Differences between patients with migraine and healthy controls at baseline in serum levels of calcitonin gene-related peptide, transcriptomic profiles on inflammatory and pain mediators, AUC and degree of habituation of the second component of the nociceptive blink reflex, resting state (RS) functional connectivity (FC) of brain networks involved in pain processing., 2a. Any of the following measures in patients showing significant changes from baseline to week 12 of eptinezumab 100mg: serum levels of CGRP, Transcriptomic profiles on inflammatory and pain mediators, AUC and degree of habituation of the second component of the nociceptive blink reflex (R2), RS FC of brain networks involved in pain processing, 2b. Correlation between changes in the identified candidate measure(s) of sensitization (serum CGRP levels, transcriptomic profiles, RS FC of pain processing brain networks, AUC, and degree of habituation of the R2 component of the nociceptive blink reflex) and changes in clinical efficacy measures following a 12-week treatment with eptinezumab at doses of 100mg.
Detailed description
1a. Differences in changes of any of the candidate measures of sensitization (serum CGRP levels, transcriptomic profiles, RS FC of pain processing brain networks, AUC, and degree of habituation of the R2 component of the nociceptive blink reflex), from week 12 to week 24, between patients receiving eptinezumab 100mg and those receiving eptinezumab 300mg;, 1b. Correlation between changes in the identified candidate measure(s) of sensitization and changes in clinical efficacy measures following a 12-week treatment with eptinezumab at doses of 300mg., 2. Differences in changes of any of the candidate measures of sensitization, from baseline to week 12, between responders and non-responders to eptinezumab 100mg. We will also assess differences in changes of any of the candidate measures of sensitization, from week 12 to week 24, between responders and non-responders to eptinezumab 300mg., 3. Correlations between changes in measures of central sensitization and measures of peripheral sensitization from baseline to week 12.
Interventions
Sponsors
Ospedale San Raffaele S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences between patients with migraine and healthy controls at baseline in serum levels of calcitonin gene-related peptide, transcriptomic profiles on inflammatory and pain mediators, AUC and degree of habituation of the second component of the nociceptive blink reflex, resting state (RS) functional connectivity (FC) of brain networks involved in pain processing., 2a. Any of the following measures in patients showing significant changes from baseline to week 12 of eptinezumab 100mg: serum levels of CGRP, Transcriptomic profiles on inflammatory and pain mediators, AUC and degree of habituation of the second component of the nociceptive blink reflex (R2), RS FC of brain networks involved in pain processing, 2b. Correlation between changes in the identified candidate measure(s) of sensitization (serum CGRP levels, transcriptomic profiles, RS FC of pain processing brain networks, AUC, and degree of habituation of the R2 component of the nociceptive blink reflex) and changes in clinical | — |
Secondary
| Measure | Time frame |
|---|---|
| 1a. Differences in changes of any of the candidate measures of sensitization (serum CGRP levels, transcriptomic profiles, RS FC of pain processing brain networks, AUC, and degree of habituation of the R2 component of the nociceptive blink reflex), from week 12 to week 24, between patients receiving eptinezumab 100mg and those receiving eptinezumab 300mg;, 1b. Correlation between changes in the identified candidate measure(s) of sensitization and changes in clinical efficacy measures following a 12-week treatment with eptinezumab at doses of 300mg., 2. Differences in changes of any of the candidate measures of sensitization, from baseline to week 12, between responders and non-responders to eptinezumab 100mg. We will also assess differences in changes of any of the candidate measures of sensitization, from week 12 to week 24, between responders and non-responders to eptinezumab 300mg., 3. Correlations between changes in measures of central sensitization and measures of peripheral sensit | — |
Countries
Italy
Outcome results
None listed