Die Studie

Die Studie ist in Englisch. Um Teil zu nehmen, müssen Sie der englischen oder holländischen Sprache mächtig sein.

Study of an investigational compound that is being developed for the treatment of Parkinson’s disease.

Particulars:

  • You must speak and understand English or Dutch to participate.
  • For this study we are looking for healthy males and females, between 18 and 50 years old who do not smoke.
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2 and your body weight is at least 50 kilograms. 
  • Males are only allowed to participate if you use sufficient contraception or have been sterilized.
  • Females are only allowed to participate in this study if you:  
    • Have been sterilized for at least 6 months before the screening (Essure® method is not allowed for this study)
    • Have been postmenopausal for at least 12 months (without menstrual periods).
  • To determine if you are suitable to participate in this study, you will undergo a medical screening visit.
  • You are only allowed to participate, if you did not participate in a drug study within the 60 days prior to the screening for this study.
  • You are willing to perform a pulmonary function test as part of the screening (separate visit) and during the study.
  • You are willing to undergo two lumbar punctures during the study.

Zeitraum

For Part E, the study consists of 1 period during which you will stay in our research facility in Groningen for 19 days (18 nights). Finally, there will be a follow-up visit including a pulmonary function test between 4 and 10 days after discharge from the research facility.

Please note: it may happen that the pulmonary function test takes place on a day other than the follow-up visit.

Group 19 days stay Follow up
Group E2b 2 Sep 2020 up to and including 20 Sep 2020 Follow-up by appointment between September 24 and 30
Group E2c 8 Sep 2020 up to and including 26 Sep 2020 Follow-up by appointment between September 30 and October 6
Group E3a 14 Oct 2020 up to and including 1 Nov 2020 Follow-up on appointment between 05 - 11 november 2020
Group E3b 28 Oct 2020 up to and including 15 Nov 2020 Follow-up on appointment between 19 - 25 November 2020
Group E3c 4 Nov 2020 up to and including 22 Nov 2020 Follow-up by appointment between 26 November - 02 December 2020

 

Aufwandsentschädigung

You will receive a gross compensation of €3573 for participation in any of the groups of Part E.

Travelling expenses will be reimbursed based on the distance traveled (€0.19 net per kilometer) with a minimum of €12 and a maximum of €160 (840 kilometers) per return, regardless of the mode of transportation.