Clinical trial • Phase IV • Neurology

RIMEGEPANT for Migraine|Episodic migraine

Phase IV trial of RIMEGEPANT for Migraine|Episodic migraine.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Migraine|Episodic migraine
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-01-2025
First CTIS Authorization Date
01-04-2025

Trial design

Randomised, active comparator arms: sumatriptan (oral; max total 100 mg according to product info) versus rimegepant (oral; max total 75 mg according to product info). nitroglycerin (glyceryl trinitrate, intravenous) used as auxiliary to induce headache (dose info in product data: max daily 0.5 µg/kg; max total 10 µg/kg). specific dosing schedules for trial administration not specified in the ctis record.-controlled, crossover Phase IV trial in Spain.

Randomised
Yes
Comparator
Active comparator arms: Sumatriptan (oral; max total 100 mg according to product info) versus Rimegepant (oral; max total 75 mg according to product info). Nitroglycerin (Glyceryl trinitrate, intravenous) used as auxiliary to induce headache (dose info in product data: max daily 0.5 µg/Kg; max total 10 µg/Kg). Specific dosing schedules for trial administration not specified in the CTIS record.
Crossover
Yes
Target Sample Size
24

Eligibility

Recruits 24 No vulnerable population selected. Only adults aged 18-60 are eligible. Informed consent required (Signature of the Inform Consent Form)..

Pregnancy Exclusion
Child-bearing women that not use one acceptable method of birth contro; Pregnant women
Vulnerable Population
No vulnerable population selected. Only adults aged 18-60 are eligible. Informed consent required (Signature of the Inform Consent Form).

Inclusion criteria

  • {"criterion_text":"- Adults between 18 and 60 years old."}
  • {"criterion_text":"- Diagnosis of migraine, with or without aura, according to the The International Classification of Headache Disorders 3rd edition."}
  • {"criterion_text":"- According to the calendar, frequency of cefalea < 10 days/month."}
  • {"criterion_text":"- Signature of the Inform Consent Form."}

Exclusion criteria

  • {"criterion_text":"- Contraindication to nitroglycerin"}
  • {"criterion_text":"- Child-bearing women that not use one acceptable method of birth contro"}
  • {"criterion_text":"- History of poor tolerance or prior hypersensitivity reaction to triptans or gepants"}
  • {"criterion_text":"- History of severe or refractory migraine attacks unresponsive to treatment with triptans, gepants, or NSAIDs"}
  • {"criterion_text":"- Preventive treatment for migraines (includes antidepressants, beta-blockers, lisinopril or candesartan, topiramate, valproic acid, botulinum toxin, or CGRP-targeted therapies)."}
  • {"criterion_text":"- Tretament with drugs acting on the central nervous system"}
  • {"criterion_text":"- Relevant medical or psychiatric diseases"}
  • {"criterion_text":"- History of unstable ischemic heart disease, cerebrovascular disease, peripheral vasculopathy"}
  • {"criterion_text":"- History of significant hepatic disease"}
  • {"criterion_text":"- Pregnant women"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Temporal evolution of GRP, AMY , VIP and PACAP-38 levels in blood and saliva (4 time points: Basal, begging migraine; peak-migraine; 2 hours post migraine treatment)","definition_or_measurement_approach":"Measurement of GRP, AMY, VIP and PACAP-38 levels in blood and saliva at 4 time points: Basal, beginning of migraine, peak-migraine, and 2 hours after migraine treatment."}

Recruitment

Planned Sample Size
24
Recruitment Window Months
20
Consent Approach
Informed consent: participants must sign the Informed Consent Form (Signature of the Inform Consent Form). Subject information and informed consent form documents are listed in trial documents. Only adult participants provide consent (no assent procedures described).

Geography

Total Number Of Sites
1
Total Number Of Participants
24

Spain

Earliest CTIS Part Ii Submission Date
13-03-2025
Latest Decision Or Authorization Date
01-04-2025
Processing Time Days
19
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurologist
Principal Investigator Name
Marta Torres Ferrús
Principal Investigator Email
Marta.torres@vallhebron.cat
Contact Person Name
Marta Torres Ferrús
Contact Person Email
Marta.torres@vallhebron.cat
Number Of Participants
24

Sponsor

Primary sponsor

Full Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
RIMEGEPANT
Active Substance
RIMEGEPANT
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
75 mg (max total)
Investigational Product Name
SUMATRIPTAN
Active Substance
SUMATRIPTAN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
100 mg (max total)
Investigational Product Name
GLYCERYL TRINITRATE
Active Substance
ISOSORBIDE DINITRATE (product lists ISOSORBIDE DINITRATE as activeSubstanceName though productName shows GLYCERYL TRINITRATE)
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
Max total 10 µg/Kg; max daily 0.5 µg/Kg

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