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

NCT05888766 | Unknown FDA Drug

• 1 other identifier: S-LT-000002620231
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

migraine biomarkers; neurophysiology; CGRP; salivary CGRP; habituation; sensitization; Rimegepant

Outcome Measures

Primary Outcomes (4)

• Salivary CGRP levels during attacks

  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

  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

  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

  Differences between responders and not responders to Rimegepant and sensitization (microvolt) at baseline.

  from enrollment to one month after the start of therapy

Secondary Outcomes (4)

• Effects of Rimegepant 75 mg on habituation after 1 month of therapy

  one month after the start of therapy

• Changes from Baseline in the sensitization after 1 month of therapy

  one month after the start of therapy

• Changes from Baseline in the pain threshold after 1 month of therapy

  one month after the start of therapy

• Changes from Baseline in the sensory detection threshold after 1 month of therapy

  one month after the start of therapy

Study Arms (1)

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

Interventions

Rimegepant 75 milligrams DRUG

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.

Episodic migraine patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome Polo Pontino - ICOT

Latina, Italy / Latina, 04100, Italy

Location

Related Publications (9)

• Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.

  PMID: 31311674 RESULT

• Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.

  PMID: 31291516 RESULT

• Alpuente A, Gallardo VJ, Asskour L, Caronna E, Torres-Ferrus M, Pozo-Rosich P. Salivary CGRP can monitor the different migraine phases: CGRP (in)dependent attacks. Cephalalgia. 2022 Mar;42(3):186-196. doi: 10.1177/03331024211040467. Epub 2021 Oct 4.

  PMID: 34601944 RESULT

• Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, Schulte LH, Hadjikhani N, Sinclair AJ, Ashina H, Schwedt TJ, Goadsby PJ. Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. 2021 Apr 17;397(10283):1496-1504. doi: 10.1016/S0140-6736(20)32162-0. Epub 2021 Mar 25.

  PMID: 33773610 RESULT

• Alpuente A, Gallardo VJ, Asskour L, Caronna E, Torres-Ferrus M, Pozo-Rosich P. Salivary CGRP and Erenumab Treatment Response: Towards Precision Medicine in Migraine. Ann Neurol. 2022 Nov;92(5):846-859. doi: 10.1002/ana.26472. Epub 2022 Aug 24.

  PMID: 36054144 RESULT

• Messlinger K, Vogler B, Kuhn A, Sertel-Nakajima J, Frank F, Broessner G. CGRP measurements in human plasma - a methodological study. Cephalalgia. 2021 Nov;41(13):1359-1373. doi: 10.1177/03331024211024161. Epub 2021 Jul 16.

  PMID: 34266288 RESULT

• Casillo F, Sebastianelli G, Di Renzo A, Cioffi E, Parisi V, Di Lorenzo C, Serrao M, Coppola G. The monoclonal CGRP-receptor blocking antibody erenumab has different effects on brainstem and cortical sensory-evoked responses. Cephalalgia. 2022 Oct;42(11-12):1236-1245. doi: 10.1177/03331024221103811. Epub 2022 May 30.

  PMID: 35637558 RESULT

• Sebastianelli G, Casillo F, Di Renzo A, Abagnale C, Cioffi E, Parisi V, Di Lorenzo C, Serrao M, Pierelli F, Schoenen J, Coppola G. Effects of Botulinum Toxin Type A on the Nociceptive and Lemniscal Somatosensory Systems in Chronic Migraine: An Electrophysiological Study. Toxins (Basel). 2023 Jan 14;15(1):76. doi: 10.3390/toxins15010076.

  PMID: 36668895 RESULT

• Coppola G, Di Lorenzo C, Schoenen J, Pierelli F. Habituation and sensitization in primary headaches. J Headache Pain. 2013 Jul 30;14(1):65. doi: 10.1186/1129-2377-14-65.

  PMID: 23899115 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Salivary samples where CGRP concentration will be quantified.

MeSH Terms

Conditions

Migraine Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gabriele Sebastianelli, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Sebastianelli, MD

CONTACT

+39 3926337082; gabriele.sebastianelli@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 5, 2023
• Study Start: July 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-05

Locations

IT (1)