Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904717
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-06-06
Brief Title:
Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
A Phase 2a Multi Centre Double-blind Randomized Placebo-controlled Parallel-group Study to Assess the Effect of 12 Weeks Treatment With Oral PXS-4728A on Microglia Activation as Measured by Positron Emission Tomography in Participants With Isolated Rapid Eye Movement Sleep Behavior Disorder
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This study is to investigate the safety and efficacy of PXS-4728A as an intervention therapy in participants with iRBD This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level
Detailed Description:
Up to 48 participants are planned to be screened and approximately 40 participants are planned to be enrolled in this study Participants will be randomized to receive either active IP or matching placebo in a ratio of 31 30 active and 10 placebo
Study participation will consist of a Screening period of up to 2 weeks to confirm participant eligibility Once confirmed as eligible participants will be able to enroll in the study and will be required to attend the clinical site on Day 1 for treatment assignment initial dosing and Baseline assessments
Oversight of the study will be provided by a Data Safety Monitoring Committee DSMC comprising the Principal Investigator PI the local Medical Monitor MM and a representative of the Sponsor at a minimum
Study participation will consist of a Screening period of up to 2 weeks to confirm participant eligibility Once confirmed as eligible participants will be able to enroll in the study and will be required to attend the clinical site on Day 1 for treatment assignment initial dosing and Baseline assessments
Oversight of the study will be provided by a Data Safety Monitoring Committee DSMC comprising the Principal Investigator PI the local Medical Monitor MM and a representative of the Sponsor at a minimum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None