Track-DM
An Ambispective 24-Month Longitudinal Natural History Study in Myotonic Dystrophy Patients Using DM-Scope Registry (TRACK-DM Study)
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
observational
100
1 country
6
Study Start
August 3, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This natural history observational study is being conducted to follow patients with DM1 or DM2 over a 2 year period to study the presence of myotonia, how it's perceived and its impact on patients quality of life. This study will be conducted at 6 study sites located in France.100 Patients will be recruited from the DM Scope Registry only. The study involves two parts. Part 1 will look back up to 18 months of past medical history that is already available from the DM Scope Registry. Part 2 will follow the same patients for 24 months, with study visits at Day 1 (Baseline), 12 months and 24 months. The goal is to better understand how myotonia symptoms and complications such as heart and other systemic problems develop and change over time. A smaller, sub-study will take place at one site, using new exploratory methods in about 40 patients with DM1 who are also part of the Track DM Study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2026
Actual (reported)July 28, 2026
Actual (reported)August 3, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in stiffness severity assessed by Visual Analog Scale (VAS)
Absolute change in VAS stiffness score (0-100mm) between Baseline and Month 12
Baseline to Month 24
Change in myotonia severity assessed by the Myotonia Behavior Scale (MBS)
Absolute change in MBS score (1-6) between Baseline and Month 24.
Baseline to Month 24
Change in disease-related activity and participation assessed by DM1-Activ
Absolute change in DM1-Activ score (0-100) between Baseline and Month 24.
Baseline to Month 24
Approximately 40 patients with DM1 who are enrolled in the Track DM core study will also participate in the substudy. These patients will undergo all visits and assessments as outlined in the core study Schedule of Assessments. In addition, patients participating in the substudy will also complete exploratory assessments at Baseline, Day 14, Month 6, Month 12 and Month 24 visits. All additional exploratory assessments will be conducted at a single site and will include a set of innovative measures designed to provide an integrative, multi-dimensional view of disease progression. These assessments will complement conventional clinical evaluations by incorporating emerging and innovative biomarkers.
90 Patients with Myotonic Dystrophy Type 1 (DM1) will be enrolled in the study and data for this group will be analyzed separately
10 Patients with Myotonic Dystrophy Type 2 (DM2) will be enrolled in the study and data for this group will be analyzed separately.
All patients will be recruited from DM-Scope Registry
Centre hospitalier Universitaire d'Angers
Angers, 75651, France
CHU de Lille - Hôpital
Lille, 59037, France
CHU LA TIMONE - Service des Maladies
Marseille, 13005, France
Alla Zozulya-Weidenfeller, PhD
Lupin Atlantis Holdings S.A.
First Submitted
June 17, 2026
First Posted
July 28, 2026
Study Start
August 3, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2029
Myotonic Dystrophy Family Registry
Change in health-related quality of life assessed by the Individualized Neuromuscular Quality of Life Questionnaire (INQoL)
Absolute change in INQoL: symptom subscores, life-domain subscores, overall total score, and treatment impact score (0-4 Likert) between Baseline and Month 24.
Baseline to Month 24
Change in walking performance assessed by the 10-Meter Walk Test (10mWT)
Absolute change in 10mWT (sec) performance between Baseline and Month 24.
Baseline to Month 24
Change in mobility and functional performance assessed by the Timed Up and Go Test (TUG)
Absolute change in TUG performance (sec) between Baseline and Month 24.
Baseline to Month 24
Change in cardiac function
Baseline and all scheduled study timepoints, including retrospective assessments up to 18 months before enrollment.
Progression of opthalmologic manifestations
Scheduled study timepoints, including retrospective assessments up to 18 months before enrollment.
Change in respiratory function
Baseline and all scheduled study timepoints, including retrospective data up to 18 months.
Change in Physical Examination Findings
Baseline and all scheduled study timepoints.
Safety and Tolerability
Throughout study participation.
Exploratory Sub-study - Change in Motor Function Measures (MFM-32)
Baseline and all scheduled study timepoints.
Exploratory Sub-Study - Video Hand Opening Test (vHOT)
Baseline and all scheduled study timepoints.
Exploratory Sub Study - QMA-Based Myotonia Assessment
Baseline and all scheduled study timepoints
Contact the study team to confirm eligibility.
Centre de référence des maladies neuromusculaires
Nantes, 44093, France
Hôpital Pitié Salpêtrière
Paris, 75013, France
CHU de Toulouse - Hôpital
Toulouse, 40031, France
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 28, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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