Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840822
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-04-23
Brief Title:
Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia
Sponsor:
Avecho Biotechnology
Organization:
Avecho Biotechnology
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep Consequences of insomnia include daytime sleepiness poor memory function decline in concentration with negative impacts on social and work activities Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None