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2024-513359-34-00CompletedPhase 4

The rimegePant in RElation to obeSiTy in mIGrainE study

Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Jan 2025

Next steps

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
40 (actual)
First submitted
15 Aug 2024
Start date
10 Mar 2025
Lead sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Diseases
Obesity, Migraine
EU CT number
2024-513359-34-00

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 40
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • 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)

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.