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NCT04634682

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

Completed NA Last updated 6 April 2022
What this trial tests

NA trial testing MYODM in Myotonic Dystrophy 1 in 30 participants. Completed in 3 December 2021.

Timeline
9 November 2020
Primary endpoint
15 November 2021
3 December 2021

Quick facts

Lead sponsorMyogem Health Company, S.L.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment30
Start date9 November 2020
Primary completion15 November 2021
Estimated completion3 December 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Myogem Health Company, S.L.

Who can join

18 and older, any sex, with Myotonic Dystrophy 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Myotonic dystrophy type 1 drug development: A pipeline toward the market.
    Pascual-Gilabert M, López-Castel A, Artero R. · · 2021 · cited 39× · PMID 33798646 · DOI 10.1016/j.drudis.2021.03.024
  2. Multisystem Symptoms in Myotonic Dystrophy Type 1: A Management and Therapeutic Perspective.
    Kuntawala DH, Vitorino R, Cruz AC, Martins F, et al · · 2025 · cited 4× · PMID 40508159 · DOI 10.3390/ijms26115350

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Other recruiting trials for Myotonic Dystrophy 1

Currently open trials in the same condition.

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Data sources for this page

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