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PRA-PXSBKN12-0H1ZA8

Epilepsy

  • M/F
  • 18 - 60 years old
  • Healthy

Clinical study of a new compound that is being developed for the treatment of epilepsy

Very positive experience. You are very well guided through the proces step by step. 

Maura

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 60 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2

Good to know about this trial

  • The study compound has been administered to people before 
  • The research consists of a single period of stay, after this a follow-up is done by phone 
  • Within group 1a & 2a only non-smokers can participate (minimum of 6 months)
  • Within group 1b & 2b only heavy smokers can participate (more than 10 sigarettes per day)

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

In this clinical study, we investigate how the study compound is processed and eliminated by the body when only the study compound is administered and when this is given in combination with an approved medicine. Each study part looks at the effect of a different approved medicine on the study compound. In addition, it is investigated how well the study compound is tolerated when it is used by healthy participants. 

 

This study consists of 4 different parts, you can participate in one group of one part.

WHO CAN PARTICIPATE?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 60 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2. 
  • Only non-smokers (minimum 3 months non-smoking) are allowed to participate in this clinical study.
  • In group 1b and 2b only heavy smokers (10 cigarettes or more per day) are allowed to participate. During your stay in our research facility you are allowed to smoke two cigarettes after every meal (breakfast, lunch and dinner) and before or at the end of a walk outside. This comes down to a maximum of 8 cigarettes per day during your period of stay. The use of e-cigarettes and vapes is not allowed.

Note:

  • You cannot participate in the study if you have participated in another clinical study in the 30 days prior to the first compound administration in this clinical study (counting from the last follow up appointment in the previous study).
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.
  • As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
    • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
    • You are using a copper intra-uterine device in combination with a condom;
    • You have passed the menopause (no periods for at least 12 months);
    • You have been sterilized or your male partner has been sterilized;
    • You are not sexually active according to your lifestyle;
    • You are only sexually active with a partner of the same sex.
  • As a male you can only participate if you meet one of the following conditions:
    • You are using a condom in combination with an additional contraception method used by your female partner;
    • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
    • You are not sexually active according to your lifestyle;
    • You are only sexually active with a partner of the same sex.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

  • You will receive a gross compensation of € 6225 for participation in part 1.
  • For participation in part 2 or part 3 of the study, you will receive a gross compensation of € 5357.
  • For participation in part 4 of the study, you will receive a gross compensation of € 5140.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE?

Period of stay and research

  • Part 1 of the study consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 28 days (27 nights), followed by a follow up call.
  • Part 2 and part 3 of the study consist of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 24 days (23 nights), followed by a follow up call.
  • Part 4 of the study consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 23 days (22 nights), followed by a follow up call.

Note: You must be available for all dates to be able to participate in this clinical study.

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.

Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!

Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.

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