An interventional study of Homeostasis Model Assessment of insulin resistance (HOMA) and MOntreal Cognitive Assessment (MoCA) in Multiple System Atrophy, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Health services research
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Among 32 studies in Multiple System Atrophy with a site in France — 6 open to participants now, 8 under way, 1 of them phase 3. Multiple System Atrophy · France.
Among the 32 studies in Multiple System Atrophy with a site in France, this one is the 10th largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2020, is one of 12 with no phase, and was the 22nd registered.
207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.
Browse Multiple System Atrophy studies →6 of the 32 studies in Multiple System Atrophy with a site in France are open now. Recruiting first, the newest first:
Teva Branded Pharmaceutical Products R&D LLC · Sites in France, United States, Germany and 4 more countries
Ages 30+
Ionis Pharmaceuticals, Inc. · Sites in France, Austria, Germany and 2 more countries
Ages 40–70
University Hospital, Bordeaux · Sites in France
Ages 18+
University Hospital, Strasbourg, France · Sites in France
Alterity Therapeutics · Sites in France
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 57 Multiple System Atrophy studies recruiting now, 24 (42%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 18 take healthy volunteers.
This study: 30 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 4
First in 2002; this study’s year is marked. 2 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 124 is above the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.
Median enrollment 77 across the 27 interventional studies, 100 across the 5 observational. Of the 23 that completed or were terminated, 5 (22%) have results posted.
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13 of 32 have an industry lead sponsor. The 10 most frequent:
University Hospital, Bordeaux is the lead sponsor of 807 studies on the registry; 198 are open to participants now.
University Hospital, Bordeaux has 8 studies filed under Multiple System Atrophy — fewer than ten, so there is no comparison to draw.
2 of the studies in Multiple System Atrophy 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 |
|---|---|
| NCT04165486Ionis Pharmaceuticals, Inc.Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON) | 2027-09 |
| NCT06568237Teva Branded Pharmaceutical Products R&D LLCA Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy | 2027-09-15 |
Add all 2 to your calendar (.ics) → With an account.
Among the 32 studies in Multiple System Atrophy with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder. The pathologic hallmark is the accumulation of aggregated alpha-synuclein in oligodendrocytes forming glial cytoplasmic inclusions. Some symptomatic treatments are available while disease-modification remains an unmet treatment need. Post-mortem findings suggest insulin resistance, i.e. reduced insulin signaling, in the brains of MSA patients. The aim of this study is to complete the target validation of insulin resistance for future treatment trials.
Multiple system atrophy (MSA) patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA belongs to the synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. We have recently shown brain insulin resistance (i.e. reduced insulin signaling) in post-mortem brain tissue of MSA patients and transgenic MSA mice, as illustrated by increased protein levels of insulin receptor substrate-1 phosphorylated at serine 312 (IRS-1pS312). Additionally, exendin-4, an approved anti-diabetic drug targeting glucagon-like peptide-1 (GLP-1) receptors, was capable of decreasing brain levels of IRS-1pS312 and preserving dopamine neurons in transgenic MSA mice. We further observed an inverse correlation between plasma neural-derived exosomal IRS-1pS312 levels and survival of dopamine neurons in transgenic MSA mice.
The aim of this study is to further characterize peripheral and central insulin resistance in MSA patients, thereby validating this target for future treatment trials. For this purpose, fasting blood glucose and insulin levels will be determined in samples of MSA patients and healthy controls for a homeostatic model assessment of insulin resistance (HOMA). Additionally, IRS-1pS312 will be measured in neural-derived plasma exosomes of MSA patients and healthy controls.
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.
Patients :
Controls:
Exclusion Criteria:
For patients and controls:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be recruited at the French Reference Center for MSA.
Biological: Homeostasis Model Assessment of insulin resistance (HOMA) · Behavioral: MOntreal Cognitive Assessment (MoCA) · Behavioral: Clinical characteristics of AMS patients · Procedure: Brain Magnetic Resonance Imaging (MRI) · Biological: Blood sampling
Healthy volunteer matched for age (+/- 5years) and sex with MSA patient.
Biological: Homeostasis Model Assessment of insulin resistance (HOMA) · Behavioral: MOntreal Cognitive Assessment (MoCA) · Procedure: Brain Magnetic Resonance Imaging (MRI) · Biological: Blood sampling
Fasting blood sample for : glucose, insulinemia, hemoglobin and lipid test to determine the Homeostasis Model Assessment of insulin resistance (HOMA) index
Cognitive evaluation with MOntreal Cognitive Assessment (MoCA)
Severity and progression of motor disorders assessed by the UMSARS scale, severity of dysautonomia assessed by the COMPASS31 scale ; quality of life questionnaire (AMS-Qol) for the level of difficulty experienced by the patient (on activities such as : move; walk; maintain balance; talk; feed)
Brain Magnetic Resonance Imaging (MRI) : putamen imaging, bridge and cerebellum; white substance hypersignals volume
Optional blood sampling for the constitution of a biological collection
HOMA Index
Homeostasis Model Assessment of insulin resistance (HOMA) index, calculated from a fasted blood glucose and insulin level between AMS patients and a formula-controlled group (insulinemia x glycemia)/22.5 insulinemia being expressed in mU/l and glucose in mmol/L.
Time frame: Day 0
IRS-1pS312 (Insulin Receptor Substrate-1, Phosphorylated at Serine 312) concentration
Mean concentration of neuronal IRS-1pS312 in plasma exosomes
Time frame: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) score
UMSARS I (0=no disorder, 48=severe disorders): is an evaluation of activities of daily life via 12 items. It evaluates language, writing, autonomy (diet; dressing; hygiene), walking and the presence of possible urinary, sexual or intestinal disorders. UMSARS II (0=no disorder, 56=severe disorders): consists of a motor examination on the basis of 14 items that allow to evaluate including facial expression, oculomotricity, oral expression, tremors or walking. UMSARS III: consists of measurements of blood pressure and heart rate in the lying and standing position for 10 minutes every minute. UMSARS IV : disability assessment from 1 to 5 (1= completely independent; 5 = totally dependent / dependent)
Time frame: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) score
UMSARS I (0=no disorder, 48=severe disorders): is an evaluation of activities of daily life via 12 items. It evaluates language, writing, autonomy (diet; dressing; hygiene), walking and the presence of possible urinary, sexual or intestinal disorders. UMSARS II (0=no disorder, 56=severe disorders): consists of a motor examination on the basis of 14 items that allow to evaluate including facial expression, oculomotricity, oral expression, tremors or walking. UMSARS III: consists of measurements of blood pressure and heart rate in the lying and standing position for 10 minutes every minute. UMSARS IV : disability assessment from 1 to 5 (1= completely independent; 5 = totally dependent / dependent)
Time frame: One year
COMPosite Autonomic Symptoms Score (COMPASS-31)
Assessment of dysautonomia. The scale consists of 31 items in 6 domains and provides an autonomic symptom score from 0 to 100. High values represent severe symptoms
Time frame: Day 0
COMPosite Autonomic Symptoms Score (COMPASS-31)
Assessment of dysautonomia. The scale consists of 31 items in 6 domains and provides an autonomic symptom score from 0 to 100. High values represent severe symptoms
Time frame: One year
AMS-Qol - Quality of life questionnaire
Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as : move; walk; maintain balance; talk; feed. It also assesses how the patient feels about his disease
Time frame: Day 0
AMS-Qol - Quality of life questionnaire
Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as : move; walk; maintain balance; talk; feed. It also assesses how the patient feels about his disease
Time frame: One year
MOntreal Cognitive Assessment (Moca) score
Moca evaluates short-term memory, visual spatial skills, executive functions, attention, concentration, working memory, language, abstraction abilities, computing and orientation in time and space. Cognitive impairment is assessed on the score of 30 points (27-30: no cognitive impairment; 21-26: mild)
Time frame: Day 0
MOntreal Cognitive Assessment (Moca) score
Moca evaluates short-term memory, visual spatial skills, executive functions, attention, concentration, working memory, language, abstraction abilities, computing and orientation in time and space. Cognitive impairment is assessed on the score of 30 points (27-30: no cognitive impairment; 21-26: mild)
Time frame: One year
Brain MRI volume
Imaging data (severity and progression of putamen atrophy, bridge and cerebellum in mm3; magnitude and progression of white substance hypersignals on T2-FLAIR images in mm3
Time frame: Day 0
Brain MRI volume
Imaging data (severity and progression of putamen atrophy, bridge and cerebellum in mm3; magnitude and progression of white substance hypersignals on T2-FLAIR images in mm3
Time frame: One year
Started Oct 2020 (actual). Primary completion is estimated for Oct 2026, 72 months after the start.
Of 42 non-industry interventional studies with no phase under Multiple System Atrophy, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 71. This study's planned 72 months is above that.
Counting every sponsor, half of 43 studies reached it within 38 months; a quarter within 24 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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