A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults with Tourette’s Disorder
This research is investigating a new medication called Ecopipam for Tourette's Disorder. It's a 'Phase 3' study, meaning it's a key stage to confirm if the drug works well and is safe. The main goal is to see how long people, especially children and teenagers aged 6 to 18, can go without their Tourette's symptoms (tics) getting worse after taking Ecopipam, compared to a dummy pill (placebo). They will get Ecopipam for a while, then some will switch to a placebo to see if their symptoms return. This helps us understand if the medicine has a lasting effect. Researchers will also look at how Ecopipam works in all adults taking part, not just younger individuals.
At a glance
What is this study about?
This study is all about understanding if a new medication called Ecopipam can effectively help people who have Tourette's Disorder. Tourette's causes involuntary movements or sounds called tics. Researchers want to see if Ecopipam can reduce these tics and, importantly, maintain that improvement over time. This is a crucial step in testing new medicines, often called a 'Phase 3' study, which means it’s designed to confirm the treatment works well and is safe for a larger group of people.
The main question this study is trying to answer is how long it takes for a person's Tourette's symptoms to get worse again after they've been taking Ecopipam. Specifically, they're very interested in children and teenagers aged 6 to 18. Participants will first take Ecopipam for a period. Then, some will be randomly switched to a dummy pill (a placebo) while others continue with Ecopipam. By watching what happens when some people stop the active drug, doctors can learn if Ecopipam has a lasting positive effect on controlling tics.
Apart from youngsters, the study will also look at how Ecopipam performs in all adults taking part, regardless of their age. The aim is to gather as much information as possible to determine if Ecopipam could be a valuable new treatment option for people living with Tourette's Disorder.
Key takeaways
- This study is testing a new medicine, Ecopipam, for Tourette's Disorder.
- It aims to see if Ecopipam can reduce tics and keep them improved over time.
- Some participants will receive a dummy pill (placebo) to compare effects.
- The study focuses on how long it takes for symptoms to return after stopping Ecopipam.
- It is a 'Phase 3' study, a crucial stage before a medicine can be approved.
- Participants must be 18 years old or older.
Who may be eligible?
To join this study, you must be 18 years old or older. The study is open to both men and women.
While the detailed description mentions children and teenagers, the listed eligibility for this particular summary indicates participants must be at least 18 years old. This suggests that the part of the study focused on children and teens might be a separate group or that the listed eligibility primarily covers the adult part of the research.
It's important to know that there will be other specific health checks and requirements to make sure the study is safe for you and that the results are clear. Your doctor or the study team will be able to explain all these details.
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's Disorder?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive a placebo?
- Are you comfortable with doctors and yourself not knowing which treatment you're on?
What does participation involve?
If you decide to take part in this study, you would first receive Ecopipam for a period. After this initial treatment phase, you would then be randomly assigned to either continue taking Ecopipam or switch to a placebo (a dummy pill that looks like the medication but contains no active drug). This part of the study is 'double-blind,' which means neither you nor your study doctor would know whether you are taking Ecopipam or the placebo. You would have regular visits to the clinic for assessments, which will likely involve checking your overall health, how your Tourette's symptoms are, and any side effects you might be having. The total duration of your participation would be confirmed by the study team, but it appears there will be a focus on what happens after 12 weeks of treatment.
Potential risks and benefits
Locations (9)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedDenmark
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedRomania
Common questions
What is Tourette's Disorder?
Tourette's Disorder is a condition that causes people to make sudden, uncontrolled movements or sounds called tics.
What is Ecopipam?
Ecopipam is a new medicine being tested to see if it can help reduce tics in people with Tourette's Disorder.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers see if the real medicine is truly effective.
What does 'double-blind' mean?
It means that neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study fair and unbiased.
How long will I be in the study?
The study's exact length for each participant will be explained by the study team, but they will be monitoring symptoms particularly at the 12-week mark after starting the medication.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.