Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-05-07
Brief Title:
Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
How to Predict Response to Acute Treatment of Migraine With Rimegepant 75 mg a Biochemical and Neurophysiological Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tools to predict which patients could better respond to abortive CGRP target therapy are still lacking We propose to investigate if biochemical salivary CGRP and neurophysiological evoked potentials biomarkers can recognize patients with the best chances of responding to Rimegepant 75 mg as an acute treatment of migraine
Detailed Description:
Background The understanding of the central role of CGRP in migraine pathophysiology led to the development of new target therapies against this molecule pathway including Rimegepant Despite the central role of the CGRP pathway in migraine it was recently discovered that some migraine attacks are non CGRP-dependent Tools to predict which patients could better respond to abortive CGRP target therapy are still lacking
Objective We propose to investigate if biochemical salivary CGRP and neurophysiological evoked potentials biomarkers can recognize patients with the best chances of responding to Rimegepant 75 mg as an acute treatment of migraine
Design of the study and methods This will be a prospective observational study The study will be subdivided into four phases screening visit T0 salivary collection observational phase follow-up visit T1 At the screening visit T0 patients with episodic migraine 20 patients which will be prescribed Rimegepant 75 mg as abortive treatment will be asked to participate in the study During the salivary collection phase patients will be instructed to collect daily saliva samples for a minimum of 7 days and a maximum of 14 days to include a minimum of 1 migraine attack During the observational phase 1-month duration patients will take Rimegepant 75 mg for abortive treatment of migraine attacks and they will be instructed to take extra saliva samples headache onset after 2h and 8h at each migraine attack Neurophysiological procedures somatosensory evoked potentials and nociceptive blink reflex will be recorded at baseline T0 and after 1 month follow-up visit T1 of administration of Rimegepant 75 mg as an abortive migraine treatment We chose somatosensory evoked potentials SSEPs to assess the integrity of the non-pain-related somatosensory lemniscal system and to study habituation phenomena and nociceptive blink reflex nBR to investigate the activity of the caudal trigeminal nucleus CGRP salivary levels will be quantified with ELISA kit
Specific aim We aim to predict Rimegepant used as abortive therapy response from baseline CGRP salivary levels and neurophysiological parameters habituation and sensitization from somatosensory evoked potentials and nociceptive blink reflex Mixing and comparing these two approaches could help to find a combination of biomarkers able to predict the treatment success We hypothesize that patients with marked habituation deficit less sensitization and more elevated CGRP salivary levels during the attack will be the patients who will respond the most to Rimegepant 75 mg as abortive migraine therapy
Objective We propose to investigate if biochemical salivary CGRP and neurophysiological evoked potentials biomarkers can recognize patients with the best chances of responding to Rimegepant 75 mg as an acute treatment of migraine
Design of the study and methods This will be a prospective observational study The study will be subdivided into four phases screening visit T0 salivary collection observational phase follow-up visit T1 At the screening visit T0 patients with episodic migraine 20 patients which will be prescribed Rimegepant 75 mg as abortive treatment will be asked to participate in the study During the salivary collection phase patients will be instructed to collect daily saliva samples for a minimum of 7 days and a maximum of 14 days to include a minimum of 1 migraine attack During the observational phase 1-month duration patients will take Rimegepant 75 mg for abortive treatment of migraine attacks and they will be instructed to take extra saliva samples headache onset after 2h and 8h at each migraine attack Neurophysiological procedures somatosensory evoked potentials and nociceptive blink reflex will be recorded at baseline T0 and after 1 month follow-up visit T1 of administration of Rimegepant 75 mg as an abortive migraine treatment We chose somatosensory evoked potentials SSEPs to assess the integrity of the non-pain-related somatosensory lemniscal system and to study habituation phenomena and nociceptive blink reflex nBR to investigate the activity of the caudal trigeminal nucleus CGRP salivary levels will be quantified with ELISA kit
Specific aim We aim to predict Rimegepant used as abortive therapy response from baseline CGRP salivary levels and neurophysiological parameters habituation and sensitization from somatosensory evoked potentials and nociceptive blink reflex Mixing and comparing these two approaches could help to find a combination of biomarkers able to predict the treatment success We hypothesize that patients with marked habituation deficit less sensitization and more elevated CGRP salivary levels during the attack will be the patients who will respond the most to Rimegepant 75 mg as abortive migraine therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None