Study of an investigational compound that is being developed for the treatment of Parkinson’s disease
Besonderheiten (auf Englisch)
- 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 32 kg/m2 and your body weight is at least 50 kilograms. The BMI shows the relation between body weight in kilograms and height in meters.
- 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.
Vergütung (auf Englisch)
You will receive a gross compensation of €3423 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.
Periode und Studie (auf Englisch)
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.
You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible.
Sonstige Information (auf Englisch)
Type of study
Soon a research study will start at PRA with a new study drug that may eventually be used for the treatment of Parkinson’s disease.
The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect on a specific protein will be investigated The study consists of 4 parts (Part A until Part E) and will be performed in approximately 190 healthy male and female volunteers. The remainder of this document concerns Part E only.
The study drug is not registered as a drug, but has been given to humans before. The study will only take place after it has been approved by the Medical Ethics Committee
Setup and duration of the study
To determine if you are suitable to participate in this study, you will undergo a medical screening visit at the research center in Groningen. If you pass the first screening you will have to return for a pulmonary test, which is also part of the screening.
Following the two screening visits, if you are eligible for participation, the study consists of 1 period during which you will stay in the research center 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 center. Please note: it may happen that the pulmonary function test takes place on a day other than the follow-up visit.
You will receive the study drug or placebo (not-active substance) during 14 days in the form of a capsule. During the study blood and urine will be taken regularly. In addition cerebrospinal fluid will be collected via a lumbar puncture twice. A fine needle will be inserted at the space between two vertebrae in the lower back. The puncture will be performed in a sitting and stooped position, under local anesthesia and will be performed by a specialist (anesthesiologist). When enough cerebrospinal fluid has been collected (maximum of 20 milliliters), the needle will be removed. After the procedure you will be brought back to your bed in a wheelchair. After that you have to lie down on your back for another 1.5 to 2 hours to decrease the risk of leakage of cerebrospinal fluid.
During the lumbar puncture and the 1.5 to 2 hours thereafter fluid will be administered using an intravenous infusion.
The actual dates will be published on our website. These are the currently planned dates; however, these may be subject to change. Please note: You have to be available for all dates for the group of choice to be able to participate in this study.
Risks and medical supervision
The study drug has only been administered in humans during the earlier parts of this study. The most commonly observed side effects are headache, nausea, fatigue and skin rash. However, there is no indication that these are related to the study drug. In addition, the study drug has been studied extensively in the laboratory and in animals. The following side effects were found in animals: decrease in blood pressure, microscopic deviations in the lungs and neurological side effects. However, these side effects were observed at very high doses, much higher than will be studied in this study.
Insertion of the needle for the collection of cerebrospinal fluid may be painful. Removing the needle is painless. Usually no complications occur during a lumbar puncture. Sometimes, during the puncture, a nerve can be hit. Then you will feel an electric pulse or a shooting pain in your leg. This can be painful for a moment, but is not harmful. This method has been performed with humans before and was generally well tolerated. The most common symptoms and complications related to the procedure are already known: headache (post-lumbar puncture headache), back pain and neck pain, discomfort during the procedure, pain at the location of the spinal catheter, dizziness and fainting.
The risks of the above-mentioned symptoms are limited, but you may suffer from these or other, still unknown, complications. You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.
Conditions for participation
You are a healthy male or female between 18 and 50 years old. You can only take part in the study if you do not smoke.
Females are only allowed to participate in this study if they were sterilized at least 6 months ago (Essure® method is not allowed for this study) or if they have been postmenopausal for at least 12 months (without menstrual periods).
The study will be done under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including chocolate milk), grapefruit (including juice) and tobacco products during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also known as theine) is allowed. Before you are allowed to take part in the study, you will be medically screened.
You will receive a maximum gross compensation of €3.423,- for participation in any of the groups in Part E. Traveling expenses will be reimbursed on the basis of traveled kilometers (€0.19 net per kilometer) with a minimum of €12 per return, and with a maximum of €160 (840 kilometers) per return, irrespective of the method of transport.
Registrieren Sie sich unverbindlich für eine der unten aufgeführten Studiengruppen
19 Tage Aufenthalt
- 12 Feb 2020 bis einschl. 1 Mär 2020
- 9 Mär 2020
19 Tage Aufenthalt
- 19 Feb 2020 bis einschl. 8 Mär 2020
- 16 Mär 2020
19 Tage Aufenthalt
- 29 Jan 2020 bis einschl. 16 Feb 2020
- 24 Feb 2020