Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900493
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-04-26
Brief Title:
The Rett Syndrome Global Registry
Sponsor:
Rett Syndrome Research Trust
Organization:
Rett Syndrome Research Trust
Study Overview
Official Title:
The Rett Syndrome Global Registry
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:
The Rett Global Registry is a fully remote global caregiver-reported registry to collect information about caring for a loved one with Rett syndrome In addition caregivers have the ability to track and graph their loved ones symptoms and care strategies over time store information for central access and opt-in to complete medical record consolidation and summary Qualified researchers and therapeutic developers may request access to de-identified aggregate information to further Rett research or assist with clinical development planning to facilitate and expedite more effective clinical trials
Detailed Description:
The Rett Syndrome Global Registry is a fully remote global caregiver-reported registry intended to meet the needs of caregivers clinicians and researchers and therapeutic developers with the goal to increase our understanding of this rare disorder support better outcomes for those with Rett syndrome and facilitate improved therapeutic development The Rett Global Registry allows families to provide data about their experience with Rett syndrome to improve their loved ones care while contributing to research Participants may opt in to track and graph symptoms and care strategies over time to support day-to-day care Participants may also access aggregate data to see similarities and differences in care strategies and consolidate their personal information in a central location Participants may opt-in to complete medical record consolidation and summary that is centrally accessible able to be shared with care providers and utilized for research
The registry database is designed and maintained to clinical trial standards and supports research and therapeutic development while meeting or exceeding federal privacy and confidentiality requirements These datasets including caregiver-reported Rett syndrome progression quality of life at home day-to-day data and consolidated medical records from office visits or hospital stays provides unique and previously unused sources of information important for improving our understanding of Rett syndrome allow additional avenues of research and support therapeutic development Specifically the registry is intended to assist with clinical development planning trial design trial endpoints and regulatory filings
The registry database is designed and maintained to clinical trial standards and supports research and therapeutic development while meeting or exceeding federal privacy and confidentiality requirements These datasets including caregiver-reported Rett syndrome progression quality of life at home day-to-day data and consolidated medical records from office visits or hospital stays provides unique and previously unused sources of information important for improving our understanding of Rett syndrome allow additional avenues of research and support therapeutic development Specifically the registry is intended to assist with clinical development planning trial design trial endpoints and regulatory filings
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