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Trial registered on ANZCTR
Registration number
ACTRN12621000319875
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
22/03/2021
Date last updated
5/07/2024
Date data sharing statement initially provided
22/03/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
An open-label, Phase IIa, multi-center, 12-week prospective study to evaluate the safety and efficacy of NOE-105 at a daily dose range of 2.5mg to 15mg in adult and adolescent male patients with Tourette Syndrome (TS).
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Scientific title
An open-label, Phase IIa, multi-center, 12-week prospective study to evaluate the safety and efficacy of NOE-105 at a daily dose range of 2.5mg to 15mg in adult male patients with Tourette Syndrome (TS).
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Secondary ID [1]
302832
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Nil known
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Universal Trial Number (UTN)
U1111-1261-4753
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Trial acronym
NOE-TTS-211
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tourette syndrome
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Condition category
Condition code
Neurological
317728
317728
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
NOE-105, formulated in oral hard gelatine capsules, administered daily, dose-ranging from 2.5mg to 15mg, during 12 weeks. The starting dose of NOE-105 is 2.5mg QD. Based on a clinical assessment and absence of tolerability issues, the investigator may increase the dose weekly by increments of 2.5mg up to a maximum of 15mg QD.
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Intervention code [1]
319108
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Treatment: Drugs
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Comparator / control treatment
No control group, open-label study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Response to the investigational drug NOE-105 rated by the Tourette Syndrome Clinical Global Impression of Change (TS-CGI-C). Response is defined as a rating of “Minimally improved” “Much improved” and “Very much improved”
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Assessment method [1]
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Timepoint [1]
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Change from Baseline to Week 12 or at patient’s discontinuation of the study if it occurs before Week12 (also called Post Treatment)
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Secondary outcome [1]
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The safety and Tolerability of NOE-105 will be assessed by the review of the patient’s data of :
AEs and SAEs
ECG and Vital signs
Blood samples analysis
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Assessment method [1]
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Timepoint [1]
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Change from Baseline to Week 12 or at patient’s discontinuation of the study if it occurs before Week12 (also called Post Treatment)
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Secondary outcome [2]
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Change in tic symptom severity by evaluating change YGTSS of the total tic scores (TTS) of the Yale Global Tic Severity Scale (YGTSS)
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Assessment method [2]
389082
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Timepoint [2]
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Change from Baseline to Week 12 or at patient’s discontinuation of the study if it occurs before Week12 (also called Post Treatment)
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Secondary outcome [3]
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Change in severity of patient’s illness rom Baseline. Assessed by TS-CGI Severity (TS-CGI-S) scale
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Assessment method [3]
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Timepoint [3]
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Change from Baseline to Week 12 or at patient’s discontinuation of the study if it occurs before Week12 (also called Post Treatment)
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Secondary outcome [4]
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The patient reported Clinical Global Impression of Change (PGI-C) vs baseline
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Assessment method [4]
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Timepoint [4]
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Change from Baseline to Week 12 or at patient’s discontinuation of the study if it occurs before Week12 (also called Post Treatment)
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Secondary outcome [5]
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Patient reported rating of the Medication Satisfaction Questionnaire (MSQ)
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Assessment method [5]
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Timepoint [5]
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Week 12 or at patient’s discontinuation of the study if it occurs before Week12 (also called Post Treatment)
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Eligibility
Key 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 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. 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. 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 <1% per year) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
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Minimum age
12
Years
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Maximum age
50
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who meet any of the following criteria will be excluded from study participation:
1. Secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism, if, in the opinion of the investigator, they will interfere with study procedures.
2. IQ<70.
Note: a previously conducted IQ level assessment can be used by the investigator and does not have to be repeated at screening for study purposes.
Additionally, in the absence of a formal IQ test result, the assessment that the targeted IQ level is reached can be based on the investigator’s judgment. The investigator can use proxies to IQ score such as the participant’s education level (i.e. completion of secondary school education) and/or their employment status.
3. Current diagnosis of bipolar disorder, schizophrenia, or Major Depressive Disorder (MDD). Patients with MDD on a stable antidepressant treatment for > 1 month can participate in the study.
4. Patients with uncontrolled seizure disorders.
5. A history of severe traumatic brain injury or stroke.
6. 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.
7. 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.
8. Positive urine drug screen for cannabinoids, cocaine, or nonprescribed opiates.
9. Participated in any clinical trial of any investigational treatments within the past 30 days.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
All patients start with a dose of 2.5mg QD and see their dose increase weekly by increments of 2.5mg up to a maximum of 15.0mg QD based on investigator clinical assessment of the effect of NOE-105 on tics associated with Tourette Syndrome and tolerability.
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Descriptive statistics will be used to summarize baseline patient characteristics, treatment with NOE-105, and safety and efficacy variables. Categorical and nominal variables will be summarized by frequency and percentage. Continuous variables will be summarized by descriptive statistics such as n, mean, median, standard deviation, minimum, and maximum.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
29/03/2021
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Actual
23/06/2021
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Date of last participant enrolment
Anticipated
29/04/2022
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Actual
20/06/2023
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Date of last data collection
Anticipated
29/07/2022
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Actual
3/11/2023
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Sample size
Target
18
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
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Recruitment hospital [1]
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The Wesley Hospital - Auchenflower
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Recruitment hospital [2]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [3]
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
32494
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3050 - Parkville
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Recruitment postcode(s) [2]
32493
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4066 - Auchenflower
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Recruitment postcode(s) [3]
42806
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
24712
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Germany
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State/province [1]
24712
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Funding & Sponsors
Funding source category [1]
307252
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Commercial sector/Industry
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Name [1]
307252
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Noema Pharma Australia PTY LTD
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Address [1]
307252
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Suite 2003, Level 20, 109 Pitt Street, Sydney NSW 2000
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Country [1]
307252
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Noema Pharma Australia Pty Ltd
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Address
Suite 2003, 109 Pitt Street, SYDNEY NSW 2000
PO Box Q175, QVB NSW 1230
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Country
Australia
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Secondary sponsor category [1]
307875
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None
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Name [1]
307875
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Address [1]
307875
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Country [1]
307875
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307347
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Royal Melbourne Hospital HREC
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Ethics committee address [1]
307347
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Level 2 South West 300 Grattan Street Parkville VIC 3052 Victoria
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Ethics committee country [1]
307347
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Australia
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Date submitted for ethics approval [1]
307347
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26/01/2021
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Approval date [1]
307347
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17/03/2021
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Ethics approval number [1]
307347
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HREC/72847/MH-2021
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Ethics committee name [2]
307620
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Belberry Limited
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Ethics committee address [2]
307620
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123 Glen Osmond Road Eastwood SA 5063
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Ethics committee country [2]
307620
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Australia
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Date submitted for ethics approval [2]
307620
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23/12/2020
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Approval date [2]
307620
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17/02/2021
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Ethics approval number [2]
307620
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2020-12-1330
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Ethics committee name [3]
310715
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MHH Ethikkomission
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Ethics committee address [3]
310715
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Carl-Neuberg_Strasse 1 30625 Hanover Germany
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Ethics committee country [3]
310715
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Germany
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Date submitted for ethics approval [3]
310715
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27/09/2021
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Approval date [3]
310715
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15/02/2022
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Ethics approval number [3]
310715
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10034_AMG_mono_2021
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Ethics committee name [4]
315646
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [4]
315646
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [4]
315646
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Australia
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Date submitted for ethics approval [4]
315646
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22/11/2022
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Approval date [4]
315646
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14/03/2023
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Ethics approval number [4]
315646
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RGS0000005794
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Summary
Brief summary
The proposed study in an open-label, Phase IIa, multi-centre, 12-week prospective study to evaluate the safety and efficacy of NOE-105 at a daily dose range of 2.5mg to 15mg in adolescent and adult male patients with Tourette Syndrome (TS).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
106922
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Dr Snehal Shah
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Address
106922
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Perth children’s Hospital, 15 Hospital Avenue, Nedlands WA 6009
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Country
106922
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Australia
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Phone
106922
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+61 8 6456 4320
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Fax
106922
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Email
106922
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Snehal.shah@health.wa.gov.au
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Contact person for public queries
Name
106923
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Snehal Shah
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Address
106923
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Perth children’s Hospital, 15 Hospital Avenue, Nedlands WA 6009
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Country
106923
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Australia
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Phone
106923
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+61 8 6456 4320
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Fax
106923
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Email
106923
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Snehal.shah@health.wa.gov.au
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Contact person for scientific queries
Name
106924
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Snehal Shah
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Address
106924
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Perth children’s Hospital, 15 Hospital Avenue, Nedlands WA 6009
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Country
106924
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Australia
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Phone
106924
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+61 8 6456 4320
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Fax
106924
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Email
106924
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Snehal.shah@health.wa.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
clinicaltrials@noemapharma.com
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF