Skip to main content
OpenTrials
Completed

NCT Number: NCT04634682

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myotonic Dystrophy 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Myotonic Disorders Myotonic Dystrophy Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Donostia

San Sebastián, Guipuzkoa, 20014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MYODM

Dietary Supplement

Formulated composition containing Theobroma cacao supplemented with caffeine

Primary outcomes

  1. Change in Individualized Neuromuscular Quality of Life (INQoL) Mean Scores

    Time frame: Screening, Month 3, Month 6

    Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Month 0) and at the end (Month 6) among the MYODM treated group and the control group. Scores range from 0-100, with 100 being a better outcome.

  2. Change in Individualized Short Form-36 (SF-36) Mean Scores

    Time frame: Screening, Month 3, Month 6

    Scores from the self-administered SF-36 questionnaire will be measured at the start of the study (Month 0), and at the end (Month 6) among patients in the MYODM-treated group and control group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes.

  3. Change in Epworth Sleepiness Scale (ESS) Scores

    Time frame: Screening, Month 3, Month 6

    ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness

Secondary outcomes

  1. Change in Physical activity and daytime sleepiness measured with GeneActiv actometer

    Time frame: Screening, Baseline, Month 6

Sponsors and collaborators

Lead sponsor

Myogem Health Company, S.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.