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NCT04634682
Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
NA trial testing MYODM in Myotonic Dystrophy 1 in 30 participants. Completed in 3 December 2021.
15 November 2021
Quick facts
| Lead sponsor | Myogem Health Company, S.L. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 9 November 2020 |
| Primary completion | 15 November 2021 |
| Estimated completion | 3 December 2021 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- MYODM
Conditions studied
- Myotonic Dystrophy 1 — all drugs for Myotonic Dystrophy 1 →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT04634682
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myotonic Dystrophy 1
Currently open trials in the same condition.
- NCT07385443 — The Spanish National Registry for Myotonic Dystrophy Type 1 · recruiting
- NCT06378216 — Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe] · recruiting
- NCT03981575 — Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04634682 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Myogem Health Company, S.L.
- Last refreshed: 6 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04634682.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing