BridgeMD
The rimegePant in RElation to obeSiTy in mIGrainE study
EU CTIS ID: 2024-513359-34-00
What this study is testing
To investigate the inhibition of the trigeminovascular reactivity after rimegepant 75 mg administration, by using the LSCI, in lean and obese healthy subjects
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Body mass index: between 18.5 to 22 kg/m2 or ≥30 kg/m2
- Males and females aged between 18 and 30 years
- General good health, based on their self-reported medical history
- 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
You likely can't join if
- 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)
- Medical history of self-reported symptoms of conditions related to cardiovascular disease, metabolic and hormonal disease, infectious disease, skin disorders, psychiatric disorders
- Current use of medication that might interfere with the measurements (such as raloxifene, tamoxifen, Mg2+ supplementation, or chronic use of analgesics)
- History of sensitivity to fruits of capsicum plants (e.g. chili peppers)
- 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
- Females who are inconsistent in administering their daily oral contraception, defined as forgetting their contraception tablets more than once a week
See the full eligibility criteria
- 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
- Body mass index: between 18.5 to 22 kg/m2 or ≥30 kg/m2
- Males and females aged between 18 and 30 years
- General good health, based on their self-reported medical history
- 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
- 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)
- Medical history of self-reported symptoms of conditions related to cardiovascular disease, metabolic and hormonal disease, infectious disease, skin disorders, psychiatric disorders
- Current use of medication that might interfere with the measurements (such as raloxifene, tamoxifen, Mg2+ supplementation, or chronic use of analgesics)
- History of sensitivity to fruits of capsicum plants (e.g. chili peppers)
- 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
- Females who are inconsistent in administering their daily oral contraception, defined as forgetting their contraception tablets more than once a week
- 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)
- Insufficient mastery of Dutch or English
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.