A study to evaluate the safety and efficacy of new drug in male patients aged 18 to 50 with Tourette Syndrome (TS).
About this study
Tourette Syndrome (TS) is a neurological (brain) disorder characterised by rapid, repetitive and involuntary muscle movements and vocalisations (tics) often involving behavioural difficulties, including:
- Attention-deficit hyperactivity disorder (ADHD)
- Obsessive-compulsive disorder (OCD).
Although TS is rare, it is two to four times more common in males and is most prominent during childhood and adolescence.
Current treatments for TS are antipsychotic drugs, which are often only moderately effective and result in a high incidence of side effects.
The investigational product, NOE-105 inhibits a specific enzyme in the body (PDE10A). The inhibition of PDE10A in the brain may lead to a reduction in the number of tics in people with TS by helping to provide a balance in the number of motor neurons (brain cells that are believed to control the tics) in the brain.
This is an open-label study, which means both the researchers and study participants know which treatment is being given. All participants will receive the NOE-105 investigational product. NOE-105 will be given to participants once a day for a maximum of 12 weeks.
Anticipated enrolment close date: 2022
Who can take part
- Meeting DSM-5 diagnostic criteria for Tourette Syndrome and requiring drug therapy
- Males aged 18 to 50 years
- Experiencing lack of benefit from their current therapy
- Have been under the care of the Investigator for at least 1 year. If not, then the Investigator should liaise closely with the patient’s clinician for the full assessment of the patient
- Eligibility criteria assessment
- Demographic information
- Medical history
- Neurological exam
- Physical exam
- Blood tests
- Current medications
- Urine drug testing
- Cognitive assessments
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
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