Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
NCT ID: NCT04634682
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-11-09
2021-12-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MYODM
MYODM, three times a day, orally
MYODM
Formulated composition containing Theobroma cacao supplemented with caffeine
No intervention
Patients will follow the same evaluation schedule but will not receive MYODM
No interventions assigned to this group
Interventions
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MYODM
Formulated composition containing Theobroma cacao supplemented with caffeine
Eligibility Criteria
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Inclusion Criteria
* Genetically proven DM1
* Able to walk independently
Exclusion Criteria
* Co-morbidity interfering with the interventions or possibly influencing outcomes.
* Participation in another clinical trial at the same time
* Unable to complete study questionnaires.
18 Years
ALL
No
Sponsors
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Myogem Health Company, S.L.
INDUSTRY
Responsible Party
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Locations
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Hospital Universitario Donostia
San Sebastián, Guipuzkoa, Spain
Countries
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Other Identifiers
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RFT-MYO-2020-01
Identifier Type: -
Identifier Source: org_study_id
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