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PRA-22318X-B

Muskel- und Nervenerkrankungen

  • M/F
  • 18 - 65 years old
  • Non-smoker
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of muscle and nerve conditions.

Register without obligation

Everything was well organised!

Julia

Participant ICON

Register without obligation

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 65 years old
  • You weigh between 50 and 100 kg
  • Your Body Mass Index (BMI) is between 18 and 30.5 kg/m2
  • Non-smoker

Good to know about this trial

  • After the second short visit, we will transfer half of the reimbursement to you
  • This trial started on February 20, 2023 and 10 groups have already started
  • The short visits of this clinical trial can also take place in Utrecht

Download the complete research overview

How does it work

How does it work?

  1. 1.

    Registering

    Register for the trail and the group you choose. After your registration, call ICON to discuss the study and make an appointment for your medical examination. This can be done from the next working day after your registration.

  2. 2.

    Medical screening

    If you meet the requirements of the trial, then a medical screening takes place at our screening center in Groningen or Utrecht.

  3. 3.

    The trial

    The clinical trial is conducted at ICON's research center in Groningen. There you will eat, sleep and stay during the trial.

  4. 4.

    Follow-up & Compensation

    A follow-up screening always takes place after the trial. You will receive the compensation for your participation, within 30 days.

Read more

Study groups

Register without obligation for the group of your preference

  • Group B1

    • 11 up to and including 20 September
    • 25 up to and including 27 September
    • 2 up to and including 10 October

    Period(s) of stay (22 days)

    • 11 up to and including 20 September
    • 25 up to and including 27 September
    • 2 up to and including 10 October

    • 17 October
    • 24 October
    • 31 October
    • 7 November
    • 21 November
    • 19 December
    • 16 January
    • 15 February

    Visit(s)

    • 17 October
    • 24 October
    • 31 October
    • 7 November
    • 21 November
    • 19 December
    • 16 January
    • 15 February

    • 4 March

    Follow-up

    • 4 March

    • €7403,-

    Compensation

    • €7403,-
    Full

  • Group B2

    • 17 up to and including 26 October
    • 31 October up to and including 2 November
    • 7 up to and including 15 November

    Period(s) of stay (22 days)

    • 17 up to and including 26 October
    • 31 October up to and including 2 November
    • 7 up to and including 15 November

    • 22 November
    • 29 November
    • 6 December
    • 13 December
    • 27 December
    • 24 January
    • 21 February
    • 22 March

    Visit(s)

    • 22 November
    • 29 November
    • 6 December
    • 13 December
    • 27 December
    • 24 January
    • 21 February
    • 22 March

    • 9 April

    Follow-up

    • 9 April

    • €7403,-

    Compensation

    • €7403,-
    Full

  • Group B3

    • 13 up to and including 22 December
    • 27 up to and including 29 December
    • 3 up to and including 11 January

    Period(s) of stay (22 days)

    • 13 up to and including 22 December
    • 27 up to and including 29 December
    • 3 up to and including 11 January

    • 18 January
    • 25 January
    • 1 February
    • 8 February
    • 22 February
    • 21 March
    • 18 April
    • 18 May

    Visit(s)

    • 18 January
    • 25 January
    • 1 February
    • 8 February
    • 22 February
    • 21 March
    • 18 April
    • 18 May

    • 7 June

    Follow-up

    • 7 June

    • €7693,-

    Compensation

    • €7693,-
    Full

  • Group B4

    • 6 up to and including 15 February
    • 20 up to and including 22 February
    • 27 February up to and including 6 March

    Period(s) of stay (22 days)

    • 6 up to and including 15 February
    • 20 up to and including 22 February
    • 27 February up to and including 6 March

    • 13 March
    • 20 March
    • 27 March
    • 3 April
    • 17 April
    • 15 May
    • 12 June
    • 12 July

    Visit(s)

    • 13 March
    • 20 March
    • 27 March
    • 3 April
    • 17 April
    • 15 May
    • 12 June
    • 12 July

    • 1 August

    Follow-up

    • 1 August

    • €7693,-

    Compensation

    • €7693,-
    Full

  • Group B4

    • 6 up to and including 15 February
    • 20 up to and including 22 February
    • 27 February up to and including 6 March

    Period(s) of stay (22 days)

    • 6 up to and including 15 February
    • 20 up to and including 22 February
    • 27 February up to and including 6 March

    • 13 March
    • 20 March
    • 27 March
    • 3 April
    • 17 April
    • 15 May
    • 12 June
    • 12 July

    Visit(s)

    • 13 March
    • 20 March
    • 27 March
    • 3 April
    • 17 April
    • 15 May
    • 12 June
    • 12 July

    • 1 August

    Follow-up

    • 1 August

    • €7693,-

    Compensation

    • €7693,-
    Full

The research physician about this research

Additional information

  • 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.
  • The study compound can possibly be used for the treatment of neuromuscular diseases (muscle control diseases). This type of disease is caused by a defect in transmission of signals from nerve cells to muscles. This can result in fluctuating muscle weakness of the arms/legs, eyes or face and can be life threatening. Current treatments for muscle control diseases are focused on treating the symptoms of the disease. The study compound is being developed to maintain and restore the cell signal transmission and to possibly counteract effects from the muscle control disease

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?

Target group

  • You are a healthy male or female.
  • You are between 18 and 65 years old.
  • Your weight is between 50 kg and 100 kg and your Body Mass Index (BMI) is between 18.0 and 30.5 kg/m2. 
  • Only non-smokers are allowed to participate in this clinical trial.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to the first compound administration in this clinical trial (counting from the last compound administration).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening including physical exam and laboratory tests. 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

  • You will receive a gross compensation of € 7693 for participation in one of the groups of part B.

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?

Period of stay and research

Part B of the trial consists of 3 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 10 days (9 nights) during the first period. The second period of stay will be 3 days (2 nights) and the final period of stay will be 9 days (8 nights). The period(s) of stay in the clinic will be followed by 9 short visits. The short visits will be spread out over a 5 month period. 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.

Frequently asked questions

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.

If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).

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.

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