Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg

May 24, 2023 updated by: Gabriele Sebastianelli, University of Roma La Sapienza

How to Predict Response to Acute Treatment of Migraine With Rimegepant 75 mg: a Biochemical and Neurophysiological Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

20 patients with episodic migraine recruited from a specialized headache Clinic (headache clinic of the Sapienza University of Rome, Polo-Pontino ICOT, Latina).

Description

Inclusion Criteria:

  • Clinical diagnosis of Episodic migraine
  • Prescription of Rimegepant 75 mg as abortive treatment for migraine
  • headache occurring on < 15 days/four weeks;
  • No other primary/secondary headache disorder;
  • No contraindication for Rimegepant 75 mg;
  • No previous exposure to any anti-CGRP drugs;
  • No prophylactic migraine treatment ongoing or in the past 3 months before participation in the study

Exclusion Criteria:

  • headache occurring >15 days/four weeks
  • Contraindication for Rimegepant 75 mg
  • Previous exposure to anti-CGRP drugs;
  • Prophylactic migraine treatment ongoing or in the past 3 months before participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Episodic migraine patients
20 patients with episodic migraine (<15 attacks/month) will be recruited from a specialized headache Clinic (headache clinic of the Sapienza University of Rome, Latina).
Drug: Rimegepant 75 milligrams
At the screening visit patients with episodic migraine, which will be prescribed Rimegepant 75 mg as abortive treatment, will be asked to participate in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary CGRP levels during attacks
Time Frame: from enrollment to one month after the start of therapy
In order to identify a biomarker that predicts the Rimegepant's response
from enrollment to one month after the start of therapy
Relationship between Rimegepant's response and salivary CGRP levels
Time Frame: from enrollment to one month after the start of therapy
Differences between responders and not responders to Rimegepant and salivary CGRP levels (pg/ml).
from enrollment to one month after the start of therapy
Relationship between Rimegepant's response and habituation at baseline
Time Frame: from enrollment to one month after the start of therapy
Differences between responders and not responders to Rimegepant and habituation (microvolt) at baseline.
from enrollment to one month after the start of therapy
Relationship between Rimegepant's response and sensitization at baseline
Time Frame: from enrollment to one month after the start of therapy
Differences between responders and not responders to Rimegepant and sensitization (microvolt) at baseline.
from enrollment to one month after the start of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Rimegepant 75 mg on habituation after 1 month of therapy
Time Frame: one month after the start of therapy
Comparison between habituation (microvolt) at baseline and habituation (microvolt) after one month of abortive therapy with Rimegepant 75 mg
one month after the start of therapy
Changes from Baseline in the sensitization after 1 month of therapy
Time Frame: one month after the start of therapy
Comparison between sensitization (microvolt) at baseline and sensitization (microvolt) after one month of abortive therapy with Rimegepant 75 mg
one month after the start of therapy
Changes from Baseline in the pain threshold after 1 month of therapy
Time Frame: one month after the start of therapy
Comparison between pain threshold (mA) at baseline and pain threshold (mA) after one month of abortive therapy with Rimegepant 75 mg
one month after the start of therapy
Changes from Baseline in the sensory detection threshold after 1 month of therapy
Time Frame: one month after the start of therapy
Comparison between sensory detection threshold (mA) at baseline and sensory detection threshold (mA) after one month of abortive therapy with Rimegepant 75 mg
one month after the start of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Gabriele Sebastianelli, MD, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 7, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-LT-000002620231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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