Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523725
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial Investigating the Safety and Efficacy of BRC-003 in Refractory Post-Traumatic Epilepsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PTE
Brief Summary:
This prospective double blind phase II study seeks to evaluate the safety and efficacy of BRC-003 a high CBD investigational product in the treatment of refractory PTE Post-Traumatic Epilepsy The research is divided into two phases an open-label dose-finding phase Part A and a subsequent randomized controlled phase Part B This design aims to provide a thorough understanding of the investigational products impact on seizure frequency seizure severity mood anxiety sleep and quality of life
Detailed Description:
Post-traumatic epilepsy PTE is a debilitating disorder characterized by recurrent seizures that develop following traumatic brain injury TBI Approximately 30 to 50 of patients with PTE may develop refractory epilepsy wherein seizures persist despite treatment with multiple antiseizure medications ASMs or other therapeutic intervention Moreover the debilitating side effects of some ASMs can impact treatment compliance and patient quality of life the side effects of ASMs may be more severe in patients with PTE
Cannabis sativa L has an extensive history of medical and therapeutic use Growing interest in the utility of cannabinoids for medical indications including epilepsy pain nausea appetite stimulation muscle spasticity and psychological disorders has led to its legalization in at least 14 countries as well as the regulatory approval of cannabis extract preparations synthetic cannabinoids and analogues Cannabidiol CBD a non-intoxicating cannabinoid has shown significant anticonvulsant properties and has received FDA Food and Drug Administration approval in three refractory seizure disorders
This prospective study seeks to evaluate the safety and efficacy of BRC-003 a high CBD investigational product in the treatment of refractory PTE The research is divided into two phases an open-label dose-finding phase Part A and a subsequent randomized controlled phase Part B This design aims to provide a thorough understanding of the investigational products impact on seizure frequency seizure severity mood anxiety sleep and quality of life
Cannabis sativa L has an extensive history of medical and therapeutic use Growing interest in the utility of cannabinoids for medical indications including epilepsy pain nausea appetite stimulation muscle spasticity and psychological disorders has led to its legalization in at least 14 countries as well as the regulatory approval of cannabis extract preparations synthetic cannabinoids and analogues Cannabidiol CBD a non-intoxicating cannabinoid has shown significant anticonvulsant properties and has received FDA Food and Drug Administration approval in three refractory seizure disorders
This prospective study seeks to evaluate the safety and efficacy of BRC-003 a high CBD investigational product in the treatment of refractory PTE The research is divided into two phases an open-label dose-finding phase Part A and a subsequent randomized controlled phase Part B This design aims to provide a thorough understanding of the investigational products impact on seizure frequency seizure severity mood anxiety sleep and quality of life
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