Migraine DisordersNCT05888766
Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg
An observational study of Migraine Disorders, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Rimegepant 75 milligrams
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sapienza University of Rome Polo Pontino - ICOT
Latina, Italy / Latina, 04100
Gabriele Sebastianelli, MD, gabriele.sebastianelli@uniroma1.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine Disorders
- Being tested
- Rimegepant 75 milligrams
- Keywords
- migraine biomarkers, neurophysiology, CGRP, salivary CGRP, habituation, sensitization, Rimegepant
- Medical subject headings
- Migraine Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 milligramsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Rimegepant 75 milligrams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary CGRP levels during attacks
In order to identify a biomarker that predicts the Rimegepant's response
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Comparison between habituation (microvolt) at baseline and habituation (microvolt) after one month of abortive therapy with Rimegepant 75 mg
Measured: one month after the start of therapy
Changes from Baseline in the sensitization after 1 month of therapy
Comparison between sensitization (microvolt) at baseline and sensitization (microvolt) after one month of abortive therapy with Rimegepant 75 mg
Measured: one month after the start of therapy
Changes from Baseline in the pain threshold after 1 month of therapy
Comparison between pain threshold (mA) at baseline and pain threshold (mA) after one month of abortive therapy with Rimegepant 75 mg
Measured: one month after the start of therapy
Changes from Baseline in the sensory detection threshold after 1 month 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
Measured: one month after the start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Sebastianelli, University of Roma La Sapienza
- Investigators
- Gabriele Sebastianelli, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888766
- Sponsor's protocol ID
- S-LT-000002620231
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31311674Lipton 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.
PubMed 31291516Alpuente 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.
PubMed 34601944Ashina 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.
PubMed 33773610Alpuente 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.
PubMed 36054144Messlinger 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.
PubMed 34266288Casillo 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.
PubMed 35637558Sebastianelli 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.
PubMed 36668895Coppola 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.
PubMed 23899115
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Predict Response to Acute Treatment of Migraine With Rimegepant 75 mg: a Biochemical and Neurophysiological Study.
- ClinicalTrials.gov ID
- NCT05888766
- Acronym / sponsor ID
- S-LT-000002620231
- Conditions
- Migraine Disorders
- Keywords
- migraine biomarkers, neurophysiology, CGRP, salivary CGRP, habituation, sensitization, Rimegepant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Episodic migraine patients | – | Drug: Rimegepant 75 milligrams20 patients with episodic migraine (<15 attacks/month) will be recruited from a specialized headache Clinic (headache clinic of the Sapienza University of Rome, Latina). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimegepant 75 milligramsAt 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. | Drug | Episodic migraine patients |
Primary outcome
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
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).
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.
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.
4 secondary outcomes
Effects of Rimegepant 75 mg on habituation after 1 month of therapy
Time frame: 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
Changes from Baseline in the pain threshold after 1 month of therapy
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Results publication: PubMed 31311674Croop 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.
- Results publication: PubMed 31291516Lipton 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.
- Results publication: PubMed 34601944Alpuente 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.
- Results publication: PubMed 33773610Ashina 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.
- Results publication: PubMed 36054144Alpuente 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.
- Results publication: PubMed 34266288Messlinger 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.
- Results publication: PubMed 35637558Casillo 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.
- Results publication: PubMed 36668895Sebastianelli 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.
- Results publication: PubMed 23899115Coppola 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Sebastianelli, MD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Sebastianelli, MD (+39 3926337082, gabriele.sebastianelli@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary CGRP levels during attacks (time frame: from enrollment to one month after the start of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888766, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.