Tourette Syndrome MedDRA version: 20.0 Level: LLT Classification code 10044127 Term: Tourette's syndrome System Organ Class: 100000004850
Conditions
Interventions
Product Code: NOE-105
Pharmaceutical Form: Capsule
INN or Proposed INN: NA
Current Sponsor code: NOE-105
Other descriptive name: NOE-105
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Noema Pharma Australia Pty Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Ability and willingness to provide written informed consent and to comply with the study procedures. 2. Fluency in the language of the investigator, study staff and the informed consent. 3. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 4. 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. 5. Male patients aged 12 to 50 years. 6. Meeting DSM-5 diagnostic criteria for Tourette Syndrome and requiring drug therapy. 7. Are in need for pharmacotherapy or are experiencing lack of benefit from their current therapy as evidenced by a CGI severity at least moderately ill or intolerance that impacts patient adherence to treatment at screening visit. 8. If applicable depending on the patient’s age, agreement to the following during the study treatment period and for at least 90 days after the last dose of study drug: • Refrain from donating sperm o Must agree to use contraception as detailed below: Agree to use a male condom (with female partner use of an additional highly effective contraceptive method with a failure rate of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism. 2. IQ 1 month can participate in the study. 4. Patients who, in the opinion of the investigator, are at risk of imminent self-harm or with a recent suicidal behavior (6 months prior to the study). 5. Patients with uncontrolled seizure disorders. 6. A history of severe traumatic brain injury or stroke. 7. Any unstable medical conditions or are currently ill (e.g., congenital heart disease, arrhythmia or cancer), which, in the investigator's judgment, will put them at a risk of major adverse event during this trial, or will interfere with safety and efficacy assessments. 8. Require cognitive-behavioral therapy (CBT, including habitual inversion therapy, cognitive therapy, relaxation training, etc.) during the trial period UNLESS started at least 8 weeks prior to study start. 9. Positive urine drug screen for cannabinoids, cocaine, or nonprescribed opiates. 10. Participated in any clinical trial of any investigational treatments within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the optimal dose range of NOE-105 that is associated with tic control in adult and adolescent patients with TS.;Secondary Objective: - To evaluate safety and tolerability of NOE-105 - To evaluate the change in tic symptom severity - To evaluate the change in severity of patient’s illness. - To evaluate the patient reported Clinical Global Impression of Change (PGI-C) - To evaluate the patient reported rating of the Medication Satisfaction Questionnaire (MSQ);Primary end point(s): “Response” as rated by the Tourette Syndrome Clinical Global Impression of Change (TS-CGI-C) at week 12 or Post Treatment. Response is defined as a rating of “Minimally improved” “Much improved” and “Very much improved”;Timepoint(s) of evaluation of this end point: BL Day 29 Day 57 Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence and severity of adverse events. Laboratory and cardiovascular safety will be also evaluated • Change from Baseline to Week 12 (or Post Treatment) in the total tic scores (TTS) of the Yale Global Tic Severity Scale (YGTSS) • Tourette Syndrome Clinical Global Impression of Severity (TS-CGI-S) scale from Baseline to Week 12 (or Post Treatment) • Patient-reported Clinical Global Impression of Change (PGI-C) as completed by patients from Baseline to Week 12 (or Post Treatment) • Patient reported rating of the Medication Satisfaction Questionnaire (MSQ) from Baseline to Week 12 (or Post Treatment);Timepoint(s) of evaluation of this end point: BL Day 29 Day 57 Day 85 | — |
Countries
Australia, Germany
Contacts
Public ContactClinical Trials
Noema Pharma
Outcome results
None listed