PRA-180481 Multiple Sclerosis € 973,-

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Description

Study of a new compound that is being developed for the treatment of Multiple Sclerosis (MS)

Requested participants

  • Male, healthy, 18 - 45 years old

Duration and visits

  • 6 days stay
  • 1 short visits

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Research details

Particulars

  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • Both non-smokers and smokers are allowed to participate in this study; however, during your stay in the research facility, smoking is not allowed.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. 8 days after the short visit, you will undergo a follow-up screening at a separate visit.
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Compensation

You will receive a gross compensation of € 973,- for participation in one of the groups.
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.

Period of stay and research

The study consists of 1 period during which you will stay in our research facility in Groningen for 6 days (5 nights), followed by 1 short visit.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Information sheet PRA-180481

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 Multiple Sclerosis (MS). The purpose of the study is to investigate to what extent the study drug is safe and tolerated. It will also be investigated how quickly and to what extent the study drug is absorbed and eliminated from the body. The study drug is not registered as a drug and has not been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee. 

Setup and duration of the study

The actual study will consist of 1 period during which you will stay in the clinical research center in Groningen, location Martini for 6 days (5 nights) followed by 1 short visit. It’s also a possibility to leave on day 3 and come back for a short visit on day 4 and day 6. 

Before and after the start of the study you will visit the medical screening centre in Groningen. You will receive the study drug or placebo once as a drink. Blood samples will be taken, and urine will be collected regularly during the study. Besides this, also 24 hours prior to planned administration up to 24 hours after administration of the study drug your heart rhythm will be monitored continuously. As long as you are connected to the device you cannot take a shower, you have to behave as relaxed as possible and have to prevent that you will sweat. As soon as you are connected, you cannot use electric devices (razor, electric toothbrush, hairdryer) anymore and you may not wear jewellery or a watch. On Day -1 and Day 1 you will receive a standardized breakfast which must be consumed entirely and a standardised lunch. 

The standardized breakfast consists of:
• 3 slices of whole-wheat bread
• 1 Dutch rusk
• 20 g margarine/low-fat margarine
• 1 portion of cheese/aged cheese/cheese spread
• 1 portion of ham/chicken breast/smoked meat/spreadable liver sausage/baloney/filet American/salami
• 2 portions of jam or other sweet spread
• 1-2 mugs of decaffeinated coffee/tea (cream and sugar optional)

The standardized lunch consists of:
• bowl of soup
• 4 slices of whole-wheat bread
• 20 g margarine/low-fat margarine
• 1 portion of cheese/aged cheese /cheese spread
• 1 portion of ham/chicken breast/smoked meat/spreadable liver sausage/baloney/filet American/salami
• 2 portions of jam or other sweet spread
• 1 cup of milk (low-fat)
• 1 mug of decaffeinated coffee/tea (cream and sugar optional)
• One portion of snack tomatoes and/or cucumber

For vegetarians, meat may be replaced by cheese, peanut butter or cheese spread.

Risks and medical supervision

Multiple sclerosis is a long-lasting inflammatory disease of the central nervous system, which concerns about 2.5 million patients worldwide, and often affects young adults. In the beginning, most patients experience recurring episodes of disability (relapses). To date, it is not possible to predict how the disease will progress, but the majority of MS patients develop some level of disability within 15 to 20 years after having been diagnosed with the disease. Multiple sclerosis is a disease in which the insulating covers of nerve cells (myelin sheaths) in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms that can amount to substantial disability. Symptoms include  numbness, visual changes (e.g., blurred or double vision), speech impairment, muscle weakness, bladder incontinence, and severe fatigue. Although the exact cause of MS is not known, it is thought to be a disease, where the person’s own immune system attacks the myelin sheath. 

Currently MS cannot be healed. Drugs that are already available for MS are more or less effective in reducing (or eliminating) the number of relapses, but do not primarily improve disability or slow disability worsening. The new study drug aims to address the latter and to improve patients’ quality of life by improving their overall neurological functioning. There is scientific data to suggest that the new study drug may result in benefits for MS patients, as it is expected to help building back the myelin sheath. 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. All potential drugs cause adverse effects; the extent to which this occurs differs. The new study drug will be administered to humans for the first time in this study, adverse effects (or so-called ‘side effects’) in humans have not been reported to date.  

Conditions for participation

You are a healthy male between 18 and 45 years old. You can only take part in the study if you do not smoke or are a light smoker. The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (milk), grapefruit (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 is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study. 

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Group 3b

€ 973,-

6 days stay

  • 16 Oct 2018 up to and including 21 Oct 2018

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Group 4a

€ 973,-

6 days stay

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€ 973,-

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  • 30 Oct 2018 up to and including 4 Nov 2018

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Group 3a

€ 973,-

6 days stay

  • 15 Oct 2018 up to and including 20 Oct 2018

short stay

Inapplicable

short visit

  • 22 Oct 2018
Group full

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