Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180421
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-12
Brief Title:
Mitochondrial Video Assessment Source Material Study
Sponsor:
The Emmes Company LLC
Organization:
The Emmes Company LLC
Study Overview
Official Title:
Development of the Mitochondrial Video Assessment MVA as an Outcome Measure for the Evaluation of Patients With Mitochondrial Myopathies
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Source material collection of videos to develop the Mitochondrial Video Assessment MVA for patients with mitochondrial myopathies
Detailed Description:
This observational research is being conducted to facilitate the development of 2 related disease-specific outcome measures assessing ease of movement in PMM and PolG clinical trials The Mitochondrial Video Assessment MVA utilizes remote video capture to assess subtle shifts in compensatory movement patterns and measure change in function over time and the Current State Questionnaire asks participants about external factors in their daily lives which may influence fluctuations in their symptoms As part of the questionnaire participants are asked to rate their own perception of their functional ability using a Patient Global Impression of Severity PGI-S scale
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