Tourette Syndrome Clinical Trial
Allevia 2: A Clinical Trial for Tourette Syndrome
Is Tourette Syndrome interrupting your day-to-day life?
As you know, tics can have a big impact on the daily life of people with Tourette Syndrome. Some people may feel anxious about having tics, especially at school/college or in the workplace, which can be an isolating experience. Behavioral therapies do not work for everyone, and medicines currently used to reduce tics are often only recommended for those with severe tics due to potential unwanted side effects. More treatment options are needed.
Introducing Allevia 2, a clinical trial for people aged 12 years and older with Tourette Syndrome. By joining the Allevia 2 clinical trial, you can help to advance our research on a potential new treatment for Tourette Syndrome.
About the Allevia 2 Clinical Trial
The Allevia 2 clinical trial will help us learn if an investigational medicine can control symptoms in people with Tourette Syndrome. This medicine has not yet been approved for the treatment of Tourette Syndrome and is currently being investigated in clinical trials.
There is evidence that Tourette Syndrome is caused by an imbalance of neurotransmitters, which are chemical messengers that send signals between brain cells. The study treatment in this clinical trial, called gemlapodect, is thought to regulate brain cells in a part of the brain that controls movements, which are activated by a neurotransmitter called dopamine. Gemlapodect is believed to normalize activity and improve how brain cells are coordinated.
Participants in this trial will receive either the study treatment or a placebo (a 'dummy' treatment that looks the same but doesn't contain an active substance). This helps us test whether any possible effects of the treatment are due to gemlapodect. The study treatment will be provided as capsules to be taken orally (swallowed) each morning. At the beginning of treatment, the dose will be gradually increased towards a maximum level. This will be done on an individual basis, depending on a person's need for a higher dose and lack of side effects.
Who Can Participate?
If you are aged 12 years or older, you might be able to take part if:
- You have been diagnosed with Tourette Syndrome.
- You need an alternative to other treatments.
- You are willing to stop using any other medicines you currently take for your Tourette Syndrome while you are in the clinical trial.
There are other requirements that the trial team can discuss with you if you are interested.
What to Expect from the Allevia 2 Clinical Trial
The Allevia 2 clinical trial will last about 5 months. You will have about 7 visits to the trial site and 1 remote visit (by telephone or computer).
Most trial visits will take about 2 to 3 hours. When you visit the site, you will have blood and urine tests and be asked to complete questionnaires about your Tourette Syndrome symptoms and general health.
Benefits and Risks
By participating in the Allevia 2 clinical trial, you will be contributing to research on Tourette Syndrome and the study treatment that could benefit people like you in the future. Your symptoms and safety will be monitored by the team throughout your time in the clinical trial.
There are risks associated with all medicines. You may experience side effects or find that your symptoms do not improve or even get worse. You are allowed to stop taking part in the clinical trial at any time and for any reason.
What are the costs to take part in this study?
You do not have to pay for the study drug, supplies, or tests that are part of the clinical study. What risks are involved for study participants? There are possible risks involved with any clinical study. The research doctor will review the risks with you, and you will be closely monitored by the research staff throughout the study.
Participants will receive a stipend of up to $600.00.