Angelman Syndrome Video Assessment (ASVA) Source Material Study

Completed

• Conditions: Angelman Syndrome

• Registration Number: NCT05637697
• Lead Sponsor: The Emmes Company, LLC

Brief Summary

This is a longitudinal, observational, nonrandomized, fully remote study enrolling approximately 55 participant-caregiver dyads. The study includes no treatments or interventions, and participants will not be asked to change their current treatments. The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-05
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Source material collection, Baseline	Baseline	The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.
Source material collection, Week 12	Week 12	The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.

Trial Locations

Locations (1)

Casimir; 🇺🇸 Kingston, Massachusetts, United States