NCT07545889Not yet recruiting
Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
The MYTH-MS study is a multicenter prospective study investigating the occurrence of clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) in the absence of radiological activity on MRI. While MS relapses are typically associated with gadolinium-enhancing lesions on MRI, some patients present with acute neurological symptoms without radiological correlates, referred to as acute clinical events with stable MRI (ACES). The frequency, mechanisms, and clinical relevance of these events remain unclear due to limitations in previous studies. The primary objective is to determine the proportion of RRMS patients experiencing a relapse without gadolinium-enhancing lesions on early brain and spinal MRI. Secondary objectives include identifying clinical, radiological, biological, and psychological predictors, assessing neurologists' diagnostic accuracy, and evaluating clinical outcomes such as disability, cognition, and quality of life over a 6-month follow-up. A total of 136 patients with recent neurological exacerbations will be included. Each participant will undergo clinical assessment, cognitive and psychological evaluation, and early MRI, with follow-up at 6 months. An ancillary study will explore blood biomarkers (NfL, GFAP, and circulating DNA) to help differentiate true inflammatory relapses from ACES. This study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 15 Apr 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 7 Sept 2029
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Multiple sclerosis
- NCT number
- NCT07545889
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 1 Sept 2026 to the primary completion date, 7 Sept 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Corticosteroid bolus or plasma exchange in the month preceding inclusion.
- Chronic treatment with corticosteroids or immunosuppressants for another pathology.
Other illness
- Diagnosis of chronic psychotic disorder.
- Infection within the past week.
- Uncontrolled cardiac, renal, or hepatic pathology.
Other
- Primary progressive or secondary progressive multiple sclerosis.
- Body temperature \> 38.5°C at V0 (baseline visit).
- Contraindication to MRI or gadolinium.
- Patient participating in another interventional study or still within an exclusion period.
- Pregnant or breastfeeding woman.
- Severe claustrophobia.
- Patient deprived of liberty (e.g., incarcerated).
Who the study is looking for
- Adult aged 18 to 70 years.
- Relapsing-Remitting Multiple Sclerosis according to the McDonald 2024 criteria.
- Patient receiving disease-modifying therapy (DMT) for multiple sclerosis.
- Most recent EDSS score between 0 and 7.0, dating back less than 1 year.
- Patient presenting with a neurological exacerbation lasting more than 24 hours and less than 7 days (excluding fatigue and pain alone).
- Patient capable of understanding the objectives and risks associated with the study and who has provided informed consent.
- Patient affiliated with or a beneficiary of a social security health insurance scheme.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospices Civils de Colmar Coordinator of this site? Confirm its status | Colmar | France | Unknown status |
| CHU de Dijon - Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Centre Hospitalier de Haguenau Coordinator of this site? Confirm its status | Haguenau | France | Unknown status |
| Chr Metz-Thionville Coordinator of this site? Confirm its status | Metz | France | Unknown status |
| Grpe Hosp Region Mulhouse & Sud Alsace Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| CHU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CHU Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.