Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
This trial consists of two parts (part 1 and part 2) and each of these parts is composed of two periods. You can only participate in one part of the trial and you will receive the compound twice: once per period.
In this trial, cerebrospinal fluid will be collected in each part via a lumbar puncture. This procedure will be performed at four different moments during the trial (twice per period). A fine needle will be inserted at the space between two vertebrae in the lower back. This procedure will be performed by an experienced specialist (anesthesiologist).
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.
WHO CAN PARTICIPATE?
Note:
As a female you can only participate if you are not pregnant, not breastfeeding and meet one of the following conditions:
As a male you can only participate if you meet one of the following conditions:
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Based on the number of short visits between the two periods (depending on the group you will participate in) you will receive the following compensation:
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
For both parts, the trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights ) in each period. There are 1 to 4 short visits between both periods. This is different between each group. The second period will be followed by 10 short visits. The follow-up visit will take place during your last short visit.
Note: You must be available for all dates to be able to participate in this clinical triail.
In this trial, cerebrospinal fluid is collected via a lumbar puncture. Researchers can extract important information from this fluid. A lumbar puncture is a safe procedure that is performed by an experienced specialist (anaesthesiologist). In the following video we explain how this works.
More information about a lumbar puncture
You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.
During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!
The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.