Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1

Myogem Health

Status: Completed

Conditions: Myotonic Dystrophy 1

Treatments: Dietary Supplement: MYODM

Study type: Interventional

Funder types: Industry

Identifiers

NCT04634682

RFT-MYO-2020-01

Details and patient eligibility

About

The purpose of this study is to determine whether MYODM (formulated composition containing Theobroma cacao supplemented with caffeine (caffeine/theobromine ratio1/1.85, w/w) 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.

Full 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 patients.The 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide informed consent
• Genetically proven DM1
• Able to walk independently

Exclusion criteria

• Regular intake of plant stanols or other nutritional supplement
• Co-morbidity interfering with the interventions or possibly influencing outcomes.
• Participation in another clinical trial at the same time
• Unable to complete study questionnaires.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

MYODM

Experimental group

Description:

MYODM, three times a day, orally

Treatment:

Dietary Supplement: MYODM

No intervention

No Intervention group

Description:

Patients will follow the same evaluation schedule but will not receive MYODM