Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621043
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 008 THC NTI164 in the Treatment of Rett Syndrome RTT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 008 THC NTI164 in the Treatment of Rett Syndrome RTT
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:
None
Brief Summary:
This 18-week open-label study examines the effectiveness of Full-Spectrum Medicinal Cannabis Plant Extract containing 008 THC NTI164 in treating Rett syndrome RTT in children and young people The study aims to determine the impact of NTI164 on RTT symptoms over a 16-week treatment period
Participants will start with a daily dose of 5 mgkg of NTI164 which will be gradually increased over four weeks until they reach either the maximum tolerated dose or 20 mgkg per day They will then maintain this dose for eight weeks Following this treatment phase the dosage will be reduced by 5 mgkg each week for four weeks until treatment concludes
The effectiveness of the treatment will be assessed using tailored questionnaires that measure changes in the patients39 conditions Additionally full blood examinations will be conducted at multiple points throughout the study to monitor the effects of the treatment
Participants will start with a daily dose of 5 mgkg of NTI164 which will be gradually increased over four weeks until they reach either the maximum tolerated dose or 20 mgkg per day They will then maintain this dose for eight weeks Following this treatment phase the dosage will be reduced by 5 mgkg each week for four weeks until treatment concludes
The effectiveness of the treatment will be assessed using tailored questionnaires that measure changes in the patients39 conditions Additionally full blood examinations will be conducted at multiple points throughout the study to monitor the effects of the treatment
Detailed Description:
This study is an 18-week open-label trial designed to assess the effectiveness of Full-Spectrum Medicinal Cannabis Plant Extract containing 008 THC NTI164 on the severity of symptoms in children and young people with Rett syndrome RTT The main objective is to determine how well NTI164 alleviates the symptoms of RTT over a 16-week treatment period
The study involves multiple phases
1 Up-titration Phase 4 weeks Treatment begins with an initial daily dose of 5 mgkg of NTI164 Over the first four weeks this dose is incrementally increased based on patient tolerance aiming for a maximum daily dose of 20 mgkg
2 Treatment Phase 8 weeks Once the maximum tolerated dose is established participants continue to receive this dose for the following eight weeks This phase focuses on maintaining a steady dosage to observe the therapeutic effects on RTT symptoms
3 Down-titration Phase 4 weeks After completing the treatment phase the dosage is systematically reduced by 5 mgkg each week for four weeks until treatment cessation This gradual reduction helps in assessing any withdrawal effects and the stability of symptom improvement post-treatment
Throughout the study the efficacy of NTI164 is evaluated using specifically designed questionnaires that track changes in the emotional behavioral and cognitive functions of the participants providing insights into how the treatment impacts various aspects of RTT Additionally full blood examinations are conducted at key points during the study to monitor the physiological responses to the treatment and to ensure the safety and tolerability of NTI164 This comprehensive approach allows for a detailed assessment of both the immediate and longer-term effects of the medicinal cannabis extract on Rett syndrome symptoms
The study involves multiple phases
1 Up-titration Phase 4 weeks Treatment begins with an initial daily dose of 5 mgkg of NTI164 Over the first four weeks this dose is incrementally increased based on patient tolerance aiming for a maximum daily dose of 20 mgkg
2 Treatment Phase 8 weeks Once the maximum tolerated dose is established participants continue to receive this dose for the following eight weeks This phase focuses on maintaining a steady dosage to observe the therapeutic effects on RTT symptoms
3 Down-titration Phase 4 weeks After completing the treatment phase the dosage is systematically reduced by 5 mgkg each week for four weeks until treatment cessation This gradual reduction helps in assessing any withdrawal effects and the stability of symptom improvement post-treatment
Throughout the study the efficacy of NTI164 is evaluated using specifically designed questionnaires that track changes in the emotional behavioral and cognitive functions of the participants providing insights into how the treatment impacts various aspects of RTT Additionally full blood examinations are conducted at key points during the study to monitor the physiological responses to the treatment and to ensure the safety and tolerability of NTI164 This comprehensive approach allows for a detailed assessment of both the immediate and longer-term effects of the medicinal cannabis extract on Rett syndrome symptoms
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