An interventional study of Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with Charcot-Marie-Tooth disease type 1A in Charcot-Marie-Tooth Type 1A Neuropathy, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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Among 23 studies in Charcot-Marie-Tooth Disease with a site in France — 6 open to participants now, 10 under way, 2 of them phase 3. Charcot-Marie-Tooth Disease · France.
Among the 23 studies in Charcot-Marie-Tooth Disease with a site in France, this one is the 11th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2020, is one of 10 with no phase, and was the 13th registered.
113 studies on the registry are indexed under Charcot-Marie-Tooth Disease; 37 are open to participants now.
Browse Charcot-Marie-Tooth Disease studies →6 of the 23 studies in Charcot-Marie-Tooth Disease with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 4+
Institut de Myologie, France · Sites in France
Ages 18–65 · Healthy volunteers
Assistance Publique Hopitaux De Marseille · Sites in France
Ages 18+
UGECAM PACA et Corse · Sites in France
Ages 18–65
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 31 Charcot-Marie-Tooth Disease studies recruiting now, 14 (45%) set no upper age limit and 13 (42%) stop at 75 or younger; 14 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 42 is close to the median of 41 across 62 interventional studies indexed under Charcot-Marie-Tooth Disease.
Median enrollment 67 across the 17 interventional studies, 53 across the 6 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
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3 of 23 have an industry lead sponsor. The 10 most frequent:
University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
University Hospital, Clermont-Ferrand has 3 studies filed under Charcot-Marie-Tooth Disease — fewer than ten, so there is no comparison to draw.
6 of the studies in Charcot-Marie-Tooth Disease with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07321977Institut de Myologie, FranceAssessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers | 2026-12-31 |
| NCT07591779University Hospital, LimogesPhysical Activity Level at Home in CMT1A Patients: Wearable Sensor Assessment | 2027-04-15 |
| NCT02596191Assistance Publique Hopitaux De MarseilleTools for Therapeutic Evaluation in Charcot-Marie-Tooth Disease Type 1A: Outcome Measures and Biomarkers | 2027-05-05 |
| NCT06845644Assistance Publique Hopitaux De MarseilleLongitudinal Quantitative Neuromuscular MRI in Neuropathic Patients | 2027-05-23 |
| NCT07038239Hospices Civils de LyonGenotype/Phenotype Correlation of MORC2 Mutations | 2027-06 |
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Among the 23 studies in Charcot-Marie-Tooth Disease with a site in France, from their registry updates:
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The main objective of this study is to explore the relationship between the onset of fall and the time taken to complete the Timed Up and Go test (TUG) in this CMT1A patient population.
The investigators hypothesize that patients with balance disorders and therefore a risk of major fall will require a longer time to perform the Timed Up and Go test. In addition, it seems important to confirm that the severity of the disease has a negative impact on the frequency of balance disorders.
Charcot-Marie Tooth disease is the most frequent and common inherited neuropathy with the various forms and subtypes. The CMT-1A is the most frequent form of the disease and represents more than eighty percent of the all subtypes. In view of different clinical elements (muscular strength deficit, walking and balance disorders, podological impairment), patients with CMT seem to be able to present an increased risk of fall. In 2017 pilot study supports this. More recently, a study by Ramdharry et al. appears to confirm this with a cohort of 252 patients with CMT, 86% of whom have experienced at least one major fall or loss of balance. This increased incidence of falls is also found in children and adolescents with CMT with consequences in terms of injury and management.
Systematic screening of the risk of falls in this population is necessary, but no prospective studies on the occurrence of falls and its detection have yet been carried out in this population.
A study focusing on this issue in order to standardize the assessment of postural control disorders using a simple test of common clinical practice seems necessary.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be involved in an evaluation program combining physical tests and self-administered questionnaires. Participants will be followed for 1 year with evaluations taking place at 6 months (occurrence of a fall) and at 1 year (the same evaluation, as initial).
Diagnostic Test: Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with Charcot-Marie-Tooth disease type 1A
The data of the gait analysis, posturography and strength analyses as well as the questionnaires' scores will be taken into account in this research. At 6 months and at 1 year, occurrence of a fall will be recorded in order to prospectively monitor this parameter. A final analysis will be carried out at 1 year from the first according to the same methods as the initial assessment.
Main explanatory variable: Time to complete the Timed Up and Go test (TUG) (in seconds)
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Investigators measures an evolution or not at 6 months and 1 years.
Time frame: 1 day , 6 months, 12 months
Main dependent variable: Self-reported occurrence of fall.
A fall book will be issued to the patient during the first consultation to trace the date, the circumstances of occurrence. Investigators seek to find an improvement or not in the number of falls at 6 months and 1 year.
Time frame: 6 months , 12 months
: Muscle Strength measured by Medical Research Council (MRC) Scale
The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. The patient's effort is graded on a scale of 0-5: Grade 5: Muscle contracts normally against full resistance and Grade 0: No movement is observed.
Time frame: Day 0 , 12 months
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the device.
Time frame: Day 0 , 12 months
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
Maximum voluntary isometric strength of the quadriceps muscles will be measured with the CYBEX device.
Time frame: Day 0 , 12 months
Body Mass Index (Kg/m²).
BMI will be calculated (weight in kilograms divided by height in meters squared).
Time frame: Day 0 , 12 months
Height (cm).
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.
Time frame: Day 0 , 12 months
Weight (Kg).
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
Time frame: Day 0 , 12 months
Sarcopenia risk.
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
Time frame: : Day 0 , 12 months
Ran from Sep 2020 to primary completion in Dec 2023, 39 months.
Of 38 non-industry interventional studies with no phase under Charcot-Marie-Tooth Disease, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 67. This study's 39 months is above that.
Counting every sponsor, half of 38 studies reached it within 29 months; a quarter within 7 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand →