Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634682
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2020-09-25
Brief Title:
Effect of MYODM on Quality of Life Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
Sponsor:
Myogem Health Company SL
Organization:
Myogem Health Company SL
Study Overview
Official Title:
Assessing the Effect of the MYODM Food Supplement on Quality of Life Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
Status:
COMPLETED
Status Verified Date:
2022-04
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:
The purpose of this study is to determine whether MYODM formulated composition containing Theobroma cacao supplemented with caffeine caffeinetheobromine ratio1185 ww is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 DM1 and improves the quality of life of these patients
Detailed Description:
Detailed Description
Myotonic Dystrophy type I DM1 is the most common form of adult muscular dystrophy affecting 1 in 8000 individuals It is an autosomal dominant disorder with multisystemic involvement of multiple organs and tissues mainly brain heart endocrine system eyes and both smooth and skeletal muscles
Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities The present project is a 6 month randomized study to assess the effect of MYODM on fatigue hypersomnia and quality of life in DM1 patientsThe patients will be randomized to one of the two study arms The active arm will receive the MYODM treatment and the control arm will not but both will follow the same evaluation program
Patients will come to the center every 3 months for evaluations
Myotonic Dystrophy type I DM1 is the most common form of adult muscular dystrophy affecting 1 in 8000 individuals It is an autosomal dominant disorder with multisystemic involvement of multiple organs and tissues mainly brain heart endocrine system eyes and both smooth and skeletal muscles
Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities The present project is a 6 month randomized study to assess the effect of MYODM on fatigue hypersomnia and quality of life in DM1 patientsThe patients will be randomized to one of the two study arms The active arm will receive the MYODM treatment and the control arm will not but both will follow the same evaluation program
Patients will come to the center every 3 months for evaluations
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