A Double-blind, Placebo-controlled, Phase IIb, Multi-center, Twelve-week Prospective Study to Evaluate the Efficacy and Safety of Gemlapodect in Adult and Adolescent Patients with Tourette Syndrome – Allevia 2
The 'Allevia 2' study is exploring a new medication called Gemlapodect for people with Tourette Syndrome. This 12-week study involves adults and teenagers (18 years and older) from different locations. Participants will be randomly assigned to receive either the active new medicine (NOE-105) or a placebo, which is a dummy pill that looks the same but contains no medicine. Neither the participants nor their doctors will know who is getting which. The main goal is to find out if Gemlapodect can reduce the number and severity of tics compared to the placebo, and to check if it's safe and well-tolerated. Researchers will also look at how it affects other aspects of Tourette's and general well-being.
At a glance
What is this study about?
This study, called 'Allevia 2,' is looking into a new medicine called Gemlapodect. It's designed for people who have Tourette Syndrome, which is a condition that causes sudden, unwanted movements or sounds called tics. The main purpose of this study is to see if Gemlapodect can help reduce these tics and if it is safe to use. This is a common way new medicines are tested before they can be widely available.
To make sure the results are fair and reliable, participants will be put into two groups by chance. One group will receive the new medicine, while the other group will receive a 'placebo.' A placebo looks exactly like the real medicine but doesn't contain any active ingredients. Neither you nor your study doctor will know which one you are taking until the study is over. This helps us truly understand if the effects are due to the medicine itself and not other factors.
Over 12 weeks, the research team will carefully monitor how participants are doing. They will pay close attention to changes in tic severity and how safe the medicine is. They'll also look at other important things like overall well-being, mood, attention, and quality of life, to get a complete picture of how the medicine might help people with Tourette Syndrome.
Key takeaways
- This study is testing a new medicine called Gemlapodect for Tourette Syndrome.
- It aims to see if the medicine can reduce tics and if it's safe for adults (18+) with Tourette Syndrome.
- Participants will receive either the new medicine or a dummy pill (placebo) for 12 weeks.
- Neither you nor your doctor will know which treatment you are receiving.
- Regular health checks and questionnaires will help doctors understand the medicine's effects.
- Your participation helps advance understanding of Tourette Syndrome treatments.
Who may be eligible?
This study is looking for adults who have Tourette Syndrome. You need to be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to join.
To be considered for the study, you'll go through a screening process. This will involve talking to the study team and having some medical checks to make sure the study is a good fit for you and that taking part would be safe.
It's important to remember that even if you meet the age and gender requirements, there might be other specific health conditions or medicines that would prevent you from joining. The study team will discuss all of this with you in detail.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Tourette Syndrome?
- Are you able to attend regular clinic visits for 12 weeks?
- Are you comfortable with the idea of potentially receiving a placebo?
- Are you not currently involved in another clinical trial testing a new medicine?
What does participation involve?
If you decide to take part in the 'Allevia 2' study, you would be involved for about 12 weeks. During this time, you would visit the study clinic regularly. At these visits, doctors and nurses would perform various checks. This includes reviews of your health, taking blood samples, checking your heart activity with an ECG, and measuring your vital signs like blood pressure.
You would be given either the new medicine (Gemlapodect) or a placebo, which is a dummy capsule, to take regularly throughout the 12 weeks. You and your study doctor wouldn't know which one you are receiving. The study team will also ask you to complete questionnaires about your tics, mood, quality of life, and other aspects of your health. Your body weight and any changes in it will also be monitored. All these assessments help the researchers understand how the medicine is affecting your body and your Tourette Syndrome.
Potential risks and benefits
Locations (6)
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- —UnverifiedGermany
Common questions
What is Tourette Syndrome?
Tourette Syndrome is a condition that causes people to make sudden, unwanted movements or sounds called tics.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real medicine but contains no active ingredients. It's used in studies to fairly test if a new medicine works.
How long will I be in the study?
The study itself will last for 12 weeks, involving regular visits and assessments during that time.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know whether you are receiving the real medicine or the placebo until the study is complete. This helps ensure fair results.
Can I leave the study at any time?
Yes, you have the right to leave the study at any point, for any reason, and it will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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