What is a clinical trial?
Clinical trials help the medical community discover possible ways to help treat a range of conditions, diseases, and disorders.
They are designed to help answer important questions about investigational medicines or ‘active medicines’, such as:
- How does this medicine work?
- How will it affect certain conditions, diseases, or disorders?
- Is this medicine safe and well-tolerated at various doses?
To find the answers to questions like these, we ask for the help of people like you to take part in clinical trials.
Why join a clinical trial?
Thousands of volunteers all around the world take part in clinical trials every year, and they decide to do it for many different reasons. For every medicine on a pharmacy shelf, volunteers like you have taken part in clinical trials and the data collected has helped make that medicine available for people to take.
Taking part in a clinical trial like ORPHEUS may help to improve medical knowledge about stuttering and has the potential to improve the quality of life for millions of people who stutter worldwide.
About the ORPHEUS study
Scientists believe that stuttering may be caused by having too much of a chemical, called dopamine, in the brain. So, it is thought that medicines which lower the amount of dopamine in the brain can help reduce stuttering. The ORPHEUS study is trying to find out if an investigational medicine, or ‘active medicine’, may help to stabilize the levels of dopamine in your brain and can help to improve speech fluency in men aged 18-55 whose stuttering started as a child.
The ORPHEUS study has been designed to understand more about how safe and tolerable the active medicine is. It has previously been tested in clinical trials for other medical conditions.
- The active medicine will be compared to a placebo. A placebo looks like the active medicine but does not contain any active ingredients. The active medicine and placebo are referred to collectively as the ‘study medicine’. The study medicines are taken as capsules, once a day by mouth.
- There is a 50/50 chance of receiving either the active medicine or the placebo, and neither you nor the study team will know which study medicine you take during the study.
- The ORPHEUS study will take around 18 weeks for you to complete. During this time, you will need to visit the study site about 12 times. There will be 2 additional visits carried out remotely.
- We will ask you to take the study medicine capsules once a day, in the morning, by mouth with food. You will receive a supply of the capsules to take at home between study visits.
- You will be seen by a study doctor with experience in managing stuttering in adults, and your health will be monitored closely. During most study visits, you will be asked to answer a number of questionnaires about your stuttering, as well as about your physical and mental wellbeing. Some study visits will also involve physical and neurological examinations. A physical examination ensures you are in good health by monitoring vitals like your weight and blood pressure, while a neurological examination checks how your nervous system is functioning.
To learn more about the ORPHEUS study please visit: www.orpheusstudy.com/ASW