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Neurological disorders

Ort der Studie

Neurological disorders

Clinical trial of an investigational compound that is being developed for the treatment of neurological disorders (such as Parkinson’s disease)

 

The research physician about this research

In this study the safety and tolerability of the study compound is investigated when administered to healthy volunteers. The trial consists of 2 parts: part A and part B. You can participate in one part of the trial. In group 4, 5 and 6 of part A and all groups of part B of the trial, a small amount of cerebrospinal fluid will be collected via an epidural. This procedure will be performed at two different moments during the trial. 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. 

Important information about this study

  • Group A1 t/m A3 will receive half of the compensation after the 5th short visit
  • The study has a short period of stay
  • The study drug will only be administered once during the study

 

Group A2b 3 Tage Aufenthalt
21 Sep 2023 bis einschl. 23 Sep 2023
kurzer Besuch
26 Sep 2023
29 Sep 2023
6 Okt 2023
13 Okt 2023
20 Okt 2023
3 Nov 2023
17 Nov 2023
1 Dez 2023
15 Dez 2023
Nachuntersuchung
Nach Vereinbarung zwischen 12 Jan 2024
€3.377
Group A3a 3 Tage Aufenthalt
20 Nov 2023 bis einschl. 22 Nov 2023
kurzer Besuch
25 Nov 2023
28 Nov 2023
5 Dez 2023
12 Dez 2023
19 Dez 2023
2 Jan 2024
16 Jan 2024
30 Jan 2024
13 Feb 2024
Nachuntersuchung
12 Mär 2024
€3.377
Group A3b 3 Tage Aufenthalt
27 Nov 2023 bis einschl. 29 Nov 2023
kurzer Besuch
2 Dez 2023
5 Dez 2023
12 Dez 2023
19 Dez 2023
27 Dez 2023
9 Jan 2024
23 Jan 2024
6 Feb 2024
20 Feb 2024
Nachuntersuchung
19 Mär 2024
€3.377

 

Who can participate?

The purpose of this study is...

  • You are a healthy male or female.
  • You are at least 18 and no more than 55 years old.
  • Your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2
  • Both non-smokers and light smokers (maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous study). For some study compounds this can be 90 days. This will be discussed during your telephone screening.
  • To determine if you are suitable to participate in this trial, 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 meet one of the following conditions:

  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized.

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.

 

Bijzonderheden

Curious about what to expect when participating in the study? Watch the video below!

 

 

Compensation

  • You will receive a gross compensation of € 3377 for participation in group 1, 2 or 3 of part A. For participation in group 4, 5 or 6 of part A of the trial, you will receive a gross compensation of € 4880. For participation in part B of the trial, you will receive a gross compensation of € 6519.

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.

 

Period of stay and research

  • For group 1, 2 or 3 of part A the trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 3 days (2 nights) followed by 10 short visits. The follow-up visit will take place during your last short visit. 
  • For group 4, 5 or 6 of part A the trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6). The first period is a stay of 4 days (3 nights) followed by one short visit. Following this short visit, you will have a short stay of 2 days (1 night) and 8 short visits. The follow-up visit will take place during your last short visit.
  • Part B of the trial consists of 4 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6). The first period is a stay of 6 days (5 nights) followed by two short visits. The second period is a short stay of 2 days (1 night) followed by one short visit. The third period is a stay of 5 days (4 nights). Following the third period, you will have one more short stay of 2 days (1 night) and 4 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 trial. 

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