The rimegePant in RElation to obeSiTy in mIGrainE study
Key facts
- Where
- Rotterdam, HollandiaSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Hollandia
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-513359-34-00
- Record updated
- 2025. január 21.
- Original description
To investigate the inhibition of the trigeminovascular reactivity after rimegepant 75 mg administration, by using the LSCI, in lean and obese healthy subjectsRead full original descriptionShow less
To investigate the inhibition of the trigeminovascular reactivity after rimegepant 75 mg administration, by using the LSCI, in lean and obese healthy subjects
Inclusion: 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.
Exclusion: Current use of medication that might interfere with the measurements (such as raloxifene, tamoxifen, Mg2+ supplementation, or chronic use of analgesics); 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; 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); 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; History of sensitivity to fruits of capsicum plants (e.g. chili peppers); Females who are inconsistent in administering their daily oral contraception, defined as forgetting their contraception tablets more than once a week; Insufficient mastery of Dutch or English.