Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621888
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 008 THC NTI164 On Paediatric Acute-onset Neuropsychiatric Syndrome PANS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 008 THC NTI164 On Paediatric Acute-onset Neuropsychiatric Syndrome PANS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CannaPANS
Brief Summary:
This study investigates the effectiveness of a medicinal cannabis extract NTI164 with 008 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 5mgkg gradually increasing to a maximum of 20mgkg 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 treatment39s efficacy using questionnaires on emotional and behavioral changes and verify the results with whole blood RNA sequencing to assess immune dysfunction
Detailed Description:
This open-label study spans 18 to 54 weeks and aims to assess the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract containing 008 THC NTI164 for treating pediatric acute-onset neuropsychiatric syndrome PANS in children The main objective is to evaluate how effective the NTI164 treatment is over the specified duration
The study protocol involves several phases
1 Up-titration phase Participants will start with a daily dosage of 5 mgkg of NTI164 incrementally increasing this dose over a four-week period until reaching either the maximum tolerated dose or 20 mgkg per day
2 Treatment phase Following the up-titration participants will continue at their maximum tolerated dose for eight weeks
3 Extension phase After the initial eight-week treatment phase participants have the option to continue at their maximum dose for up to an additional 46 weeks totaling a possible 54 weeks of treatment
4 Down-titration phase At the conclusion of the treatment or extension phases the dosage will be gradually reduced by 5 mgkg over four weeks until the participant39s involvement in the study ends
The effectiveness of NTI164 will be monitored through both participant- and psychologist-led questionnaires which are designed to track changes in the emotions and behavior of the patients with PANS Additionally the study will employ whole blood RNA sequencing as a method to validate the presence of an immune dysfunction signature aiming to provide a biomarker for response to treatment This comprehensive approach seeks to ensure a thorough evaluation of NTI164s potential benefits in alleviating the symptoms of PANS
The study protocol involves several phases
1 Up-titration phase Participants will start with a daily dosage of 5 mgkg of NTI164 incrementally increasing this dose over a four-week period until reaching either the maximum tolerated dose or 20 mgkg per day
2 Treatment phase Following the up-titration participants will continue at their maximum tolerated dose for eight weeks
3 Extension phase After the initial eight-week treatment phase participants have the option to continue at their maximum dose for up to an additional 46 weeks totaling a possible 54 weeks of treatment
4 Down-titration phase At the conclusion of the treatment or extension phases the dosage will be gradually reduced by 5 mgkg over four weeks until the participant39s involvement in the study ends
The effectiveness of NTI164 will be monitored through both participant- and psychologist-led questionnaires which are designed to track changes in the emotions and behavior of the patients with PANS Additionally the study will employ whole blood RNA sequencing as a method to validate the presence of an immune dysfunction signature aiming to provide a biomarker for response to treatment This comprehensive approach seeks to ensure a thorough evaluation of NTI164s potential benefits in alleviating the symptoms of PANS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None