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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06621888
Registration number
NCT06621888
Ethics application status
Date submitted
11/09/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Titles & IDs
Public title
Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)
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Scientific title
Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)
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Secondary ID [1]
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ACTRN12622001419752
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Secondary ID [2]
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NTIPANS1
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Universal Trial Number (UTN)
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Trial acronym
CannaPANS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
PANS Pediatric Acute-Onset Neuropsychiatric Syndrome
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - NTI164
Experimental: Active NTI164 Group - Participants in this group receive Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC (NTI164) to treat pediatric acute-onset neuropsychiatric syndrome (PANS). The treatment begins with an up-titration phase where doses start at 5 mg/kg daily and increase to a maximum of 20 mg/kg. This is followed by an 8-week treatment phase at the maximum tolerated dose. Participants have the option to extend this phase up to 54 weeks. The study concludes with a down-titration phase, gradually reducing the dose over 4 weeks. Efficacy is assessed through psychological questionnaires and immune function tests.
Treatment: Drugs: NTI164
This intervention uses Full-Spectrum Medicinal Cannabis Plant Extract with a low THC concentration of 0.08% (NTI164), specifically formulated to treat pediatric acute-onset neuropsychiatric syndrome (PANS). The dosing regimen is carefully structured to increase from an initial 5 mg/kg per day up to a maximum of 20 mg/kg, tailored to individual tolerance levels. This gradual titration and the option to extend treatment up to 54 weeks distinguishes it from other interventions that may use different concentrations of THC or shorter treatment durations. The efficacy of NTI164 is rigorously assessed through psychological evaluations and biomarker analyses.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Global Impression Scale-Improvement
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Assessment method [1]
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The CGI-I (Clinical Global Impressions - Improvement) scale rates patient improvement on a scale from 1 to 7. Lower scores indicate better improvement.
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Timepoint [1]
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Baseline (pre-dose), 4, 12, 16 weeks post-commencement of treatment. Additional timepoints for Extension phase: Weeks 28, 40, 52 post-commencement of treatment.
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Primary outcome [2]
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Revised Childrens Anxiety and Depression Scale-Parent Version
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Assessment method [2]
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The RCADS-P (Revised Child Anxiety and Depression Scale - Parent Version) assesses anxiety and depression in children, with individual item scores ranging from 0 to 3. Higher scores indicate more severe symptoms, meaning lower scores suggest better emotional well-being.
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Timepoint [2]
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Baseline (pre-dose), 4, 12, 16 weeks post-commencement of treatment. Additional timepoints for Extension phase: Weeks 28, 40, 52 post-commencement of treatment.
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Secondary outcome [1]
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Yale Global Tic Severity Scale
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Assessment method [1]
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The Yale Global Tic Severity Scale (YGTSS) measures the severity of tics in individuals, with individual item scores ranging from 0 to 5 for both motor and vocal tics. Higher scores indicate more severe tics and lower scores reflect better tic control.
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Timepoint [1]
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Baseline (pre-dose), 4, 12, 16 weeks post-commencement of treatment. Additional timepoints for Extension phase: Weeks 28, 40, 52 post-commencement of treatment.
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Secondary outcome [2]
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Children's Yale-Brown Obsessive-Compulsive Scale
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Assessment method [2]
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The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) assesses the severity of obsessive-compulsive symptoms in children, with individual item scores ranging from 0 to 4. Higher scores indicate more severe symptoms and lower scores suggest better symptom control.
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Timepoint [2]
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Baseline (pre-dose), 4, 12, 16 weeks post-commencement of treatment. Additional timepoints for Extension phase: Weeks 28, 40, 52 post-commencement of treatment.
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Secondary outcome [3]
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Conners Scale
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Assessment method [3]
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The Conners\' Scale measures behavioural problems, with individual item scores ranging from 0 to 3. Higher scores indicate more severe behavioural issues and lower scores reflect better behavioural functioning.
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Timepoint [3]
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Baseline (pre-dose), 4, 12, 16 weeks post-commencement of treatment. Additional timepoints for Extension phase: Weeks 28, 40, 52 post-commencement of treatment.
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Secondary outcome [4]
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EQ-5D-Y
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Assessment method [4]
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The EQ-5D-Y (EuroQol Five-Dimension Youth) is a measure of health-related quality of life in children and adolescents. It assesses five dimensions, with individual item scores ranging from 1 to 3. A higher score indicates more health-related difficulties, meaning lower scores reflect better quality of life.
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Timepoint [4]
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Baseline (pre-dose), 4, 12, 16 weeks post-commencement of treatment. Additional timepoints for Extension phase: Weeks 28, 40, 52 post-commencement of treatment.
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Secondary outcome [5]
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Blood Transcriptomic Signature
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Assessment method [5]
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The Blood Transcriptomic Signature outcome assesses changes in gene expression in PANS children post-NTI164 treatment, compared to baseline and controls. RNA sequencing of blood samples will identify modifications in the transcriptomic profile, providing insights into the treatment's impact on molecular processes.
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Timepoint [5]
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Baseline (pre-dose) and 16 weeks post-commencement of treatment.
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Eligibility
Key inclusion criteria
* 1 - 17 years of age
* Patients who fulfil PANS criteria
* Acute onset of OCD or severely restricted food intake
* Concurrent presentation of additional neuropsychiatric symptoms from at least 2 of the following 7 categories: anxiety, emotional lability/depression, irritability, aggression or severely oppositional behaviours, behavioural regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g. sleep disturbances, enuresis or increase in urinary frequency)
* Symptoms not better explained by a known neurologic or medical disorder (e.g. Sydenham's chorea)
* RCADS-P scores of >65 (a scale of anxiety, social phobia, panic disorder, OCD, and low mood, a score of >65 infers moderate-significant impairment)
* Other patient medications (e.g. anti-psychotics) must be stable for at least 12 weeks prior to trial participation
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Minimum age
1
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Infection and/or antibiotic use in the 2 weeks prior to trial participation (i.e. baseline blood tests and commencement of NTI164)
* Recent changes to other patient medication (e.g. addition or escalation of anxiolytics, anti-depressants etc; medication dosage must be stable for at least 12 weeks prior to trial participation)
* Intellectual disability preventing adequate assent from patient, or that would affect reporting throughout trial; patients with intellectual disability must still have the capacity to verbalise their symptoms/experiences
* Ongoing immunomodulating or immunosuppressive treatment use in the previous 12 weeks, including steroids, IVIG, antibiotics, low-dose naltrexone, mycophenolate, Rituximab etc.
* Currently using or has used recreational or medicinal cannabis or cannabinoid-based medications (e.g. Sativex ®, Epidiolex ®) in the previous 12 weeks and/or is unwilling or unable to abstain for the duration of the trial
* Underlying renal impairment, cardiovascular issues (e.g. arrhythmia), current or previous thrombosis
* Impaired hepatic function, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) or total bilirubin (TBL) > 2 x ULN; this criterion can only be confirmed once baseline laboratory results are available and participants who fail this criterion will not proceed in this study
* Other diagnosed neurological condition likely to be contributing to OCD/neuropsychiatric symptoms (e.g. Huntington's disease)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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The Childrens Hospital at Westmead - Sydney
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Recruitment hospital [2]
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Monash Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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2145 - Sydney
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Recruitment postcode(s) [2]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Fenix Innovation Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Neurotech International
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study investigates the effectiveness of a medicinal cannabis extract (NTI164) with 0.08% THC in treating children with pediatric acute-onset neuropsychiatric syndrome (PANS) over a period of 18 to 54 weeks. Participants, aged 18 to 54, will start with a daily dose of 5mg/kg, gradually increasing to a maximum of 20mg/kg over four weeks. After reaching their maximum tolerated dose, they will maintain this dose for eight weeks, with an option to extend up to 54 weeks. The study will measure the treatment\'s efficacy using questionnaires on emotional and behavioral changes, and verify the results with whole blood RNA sequencing to assess immune dysfunction.
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Trial website
https://clinicaltrials.gov/study/NCT06621888
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06621888
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