The rimegePant in RElation to obeSiTy in mIGrainE study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

10 Mar 2025 → 13 Nov 2025

Decision date (initial)

2024-11-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Therapy, Safety, Pharmacokinetic

To investigate the inhibition of the trigeminovascular reactivity after rimegepant 75 mg administration, by using the LSCI, in lean and obese healthy subjects

Secondary objectives 4

1. To investigate the correlation between sex steroids and trigeminovascular reactivity
2. To investigate the correlation between rimegepant blood levels and trigeminovascular reactivity
3. To investigate the correlation between CGRP blood levels and trigeminovascular reactivity
4. To investigate the correlation between body composition and trigeminovascular reactivity

Conditions and MedDRA coding

Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent must be obtained from the subjects in accordance with the requirements of the ethics committee, prior to the initiation of protocol procedures
2. Body mass index: between 18.5 to 22 kg/m2 or ≥30 kg/m2
3. Males and females aged between 18 and 30 years
4. General good health, based on their self-reported medical history
5. All females should have a regular menstrual cycle of 25-35 days or only use oral hormonal contraceptive regularly and consistently for at least one month

Exclusion criteria 8

1. History of migraine or current migraine (including aura without headache), or cluster headache, as determined with the official International Classification of Headache Disorders (version 3)
2. Medical history of self-reported symptoms of conditions related to cardiovascular disease, metabolic and hormonal disease, infectious disease, skin disorders, psychiatric disorders
3. Current use of medication that might interfere with the measurements (such as raloxifene, tamoxifen, Mg2+ supplementation, or chronic use of analgesics)
4. History of sensitivity to fruits of capsicum plants (e.g. chili peppers)
5. Current pregnancy or breastfeeding, a positive pregnancy test prior to dispensing the investigational study medication, at baseline, or planning to become pregnant before or during the study
6. Females who are inconsistent in administering their daily oral contraception, defined as forgetting their contraception tablets more than once a week
7. Current or former non-incidental smoking (all substances), (incidental smoking is defined as a maximum of 1 cigarette per month), and/or alcohol consumption of more than seven alcohol units per week, and/or current or prior substance dependence/addition (alcohol, illicit drugs, narcotics, tranquilizers, analgesics)
8. Insufficient mastery of Dutch or English

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The inhibition of induced dermal blood flow (DBF) responses, before and after rimegepant administration, expressed as the difference in maximal DBF responses (ΔDBF) to capsaicin and electrical stimulation (ES), and stratified for body weight.

Secondary endpoints 3

1. Blood: sex steroid levels, rimegepant concentration, CGRP
2. Body composition parameters: total body weight, total body water (TBW), free mass (FFM), fat mass (FM), soft lean mass (SLM), skeletal muscle mass (SMM), phase angle (PA)
3. Similar outcome measures will be used as described for the primary objective, but stratified for sex steroids, rimegepant concentrations, CGRP and body composition parameters.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Department of Internal Medicine, Devision Pharmacology and Vascular Medicine

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Department of Internal Medicine, Devision Pharmacology and Vascular Medicine

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications