Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

This study is investigating a potential new medicine called Ecopipam in children, teenagers, and adults who have Tourette's Syndrome. The main goal is to understand how safe this medicine is when taken for a long time, and if people can comfortably take it. Participants will take Ecopipam tablets, starting with a small dose that slowly increases over four weeks until they reach a regular daily dose. Researchers will regularly check participants at the clinic for up to two years to see how they are doing and if they experience any side effects. There will also be follow-up calls after the medicine is stopped to ensure everything is okay. This study wants to make sure Ecopipam is safe for long-term use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Emalex Biosciences Inc.

Enrolment target

150

Start

16 Aug 2023

Estimated completion

01 Mar 2027

Tourette Syndrome

What is this study about?

This research study is looking into a medicine called Ecopipam for people who have Tourette's Syndrome. We want to understand how safe Ecopipam is and how well people can take it over a long period. This is important because Tourette's Syndrome is a long-term condition, and any new medicine needs to be safe for ongoing use. The study includes children from 6 years old, teenagers, and adults.

The main aim of this study is to gather information on the long-term safety of Ecopipam tablets. This means we'll be watching closely for any side effects or anything unexpected that might happen while people are taking the medicine. We'll also see if people find the medicine easy to take and stick with over time. The information we collect will help doctors and researchers understand if Ecopipam could be a helpful and safe treatment option for Tourette's Syndrome in the future.

This study is building on previous research. Participants joining this particular study would have already taken part in an earlier study with Ecopipam. This allows researchers to continue monitoring their health and the medicine's effects over an even longer period. This type of long-term study is crucial for fully understanding a medicine's profile before it can become widely available.

Key takeaways

This study is testing the long-term safety of Ecopipam for Tourette's Syndrome.
It includes children (6+), teenagers, and adults who took part in a previous Ecopipam study.
Participation involves taking Ecopipam tablets and regular health check-ups for up to 2 years.
The dose will slowly increase over the first 4 weeks, then remain stable.
Your health will be monitored carefully during and after the study medication.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you must be at least 6 years old. You would also need to have previously taken part in one of the specific Ecopipam studies (EBS-101-TD-301, EBS-101-OL-001, or PSY302A) and completed most of the visits from that study.

Crucially, you would have shown some benefit from Ecopipam in the earlier study and doctors would agree that it's good for you to continue taking it. If you are sexually active, you'll need to use effective contraception during the study and for 30 days after your last dose. Also, young people under 18 will need a parent or guardian to give permission, and they will also need to agree themselves.

You would not be able to join this study if you had to stop participating in one of the previous Ecopipam studies because you couldn't be reached, you changed your mind, you didn't follow the study instructions, or the doctors decided it wasn't right for you. People with certain other health problems like a serious mood disorder, unstable mental health conditions, severe kidney or liver problems, or other specific neurological conditions (like Huntington's or Parkinson's disease) would also not be able to join. Your doctor will check your health carefully to make sure the study is suitable for you.

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 at least 6 years old?
Have you previously participated in a specific Ecopipam study (EBS-101-TD-301, EBS-101-OL-001, or PSY302A)?
Did you complete most of the visits in that previous study and show some benefit from Ecopipam?
Do you use effective contraception if you are sexually active, and for 30 days after stopping the study medicine?
Do you have a diagnosis of Tourette's Syndrome with both motor and vocal tics that affect your daily life?
Do you *not* have certain other serious health conditions like unstable mood disorders, severe kidney/liver problems, or other neurological diseases?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue taking Ecopipam tablets. For the first four weeks, the dose you take will slowly be increased until you reach a regular daily dose that is right for your weight. After this, you will continue on this regular dose.

You'll have regular check-ups at the study clinic. These will happen at certain times over the course of up to two years (for example, monthly for the first year, then every few months after that). At these visits, the study team will carry out health checks and ask you questions to see how you are feeling and if you're experiencing any side effects. You'll also have blood tests and other assessments to monitor your health.

After you stop taking Ecopipam at the end of the study, there will be two more follow-up visits, one 7 days later and one 14 days later, to check on your health. There will also be a phone call about a month after your last dose. The entire study could last for up to two years, plus the follow-up period.

Potential risks and benefits

Participating in this study might offer a potential benefit by allowing you to continue taking a medicine that has previously shown some benefit for your Tourette's Syndrome. It also helps contribute to medical knowledge, which could help others with Tourette's in the future. As with any medicine, there are potential risks, including side effects from Ecopipam, which the study team will explain in detail. There is also the inconvenience of regular clinic visits and health checks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (67)

Harmonex, Inc.
Verified postcode
Dothan, United States
Arkansas Children's Hospital
Verified postcode
Little Rock, United States
Advanced Research Center
Verified postcode
Anaheim, United States
CenExel CIT-IE
Verified postcode
Bellflower, United States
Cortica Site Network
Verified postcode
Glendale, United States
Cortica Site Network - San Rafael
Verified postcode
San Rafael, United States
Yale School of Medicine
Verified postcode
New Haven, United States
Childrens National Hospital
Verified postcode
Washington D.C., United States
NW FL Clinical Research Group, LLC
Verified postcode
Gulf Breeze, United States
Research in Miami Inc
Verified postcode
Hialeah, United States
University of Miami Miller School of Medicine
Verified postcode
Miami, United States
Florida International Research Center
Verified postcode
Miami, United States

Common questions

What is Ecopipam?

Ecopipam is a medicine being studied for Tourette's Syndrome. This study aims to understand its long-term safety.

How long will I be in the study?

You could be in the study for up to two years, plus a short follow-up period after you stop taking the medicine.

Do I have to pay to join the study?

No, you do not have to pay to participate in the study. All study-related medication and assessments are provided.

What happens if I experience side effects?

The study team will closely monitor you for any side effects and provide you with care and guidance if they occur. Always tell them how you are feeling.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your decision won't affect your future medical care.