1. Multiple Sclerosis 2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive MedDRA version: 9.1 Level: LLT Classification code 10028246 Term: Multiple sclerosis aggravated MedDRA version: 9.1 Level: LLT Classification code 10028247 Term: Multiple sclerosis like syndrome MedDRA v
Conditions
Sponsors
C.H.U. de RENNES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. age between 18 and 45 years 2. Patients with a CIS—defined as a first neurologic event suggestive of MS lasting for at least 24 hours and with symptoms and signs indicating a single lesion (monofocal) 3. Presence of a first monosymptomatic neurologic event suggestive of MS that lasted for at least 24 hours 4. Presence of at least two clinically silent lesions on their T2-weighted brain MRI baseline scan 5. With an Expanded Disability Status Scale (EDSS) score at baseline between 0 and 5 6. USPIO (SH U 555 C) injection has to be performed within four weeks after start of clinical event 7. Patients have to be in-patients for a minimum of 24 hours after the first USPIO (SH U 555 C) injection 8. Patients must be compliant with study protocol 9. Patients must have given their written consent to participate in this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Non-adult patients 2. Any patients not fulfilling the criteria of a monosymptomatic clinically isolated syndrome suggestive of multiple sclerosis 3. Any monosymptomatic CIS patients being included after four weeks of clinical onset of their neurologic symptoms 4. Any monosymptomatic CIS patients having received steroid treatment before acquisition of the baseline USPIO MR scan 5. Patients in whom any disease other than MS could explain their signs and symptoms, 6. Patients with any previous episode that could possibly be attributed to an acute demyelinating event will be excluded, 7. Patients with complete transverse myelitis or bilateral optic neuritis will be excluded, 8. Patients who had received prior immunosuppressive or immunomodulatory treatment will be excluded. 9. Patients which cannot be in-patients for a minimum of 24 hours after the first USPIO (SH U 555 C) injection 10. Female patients without efficient contraception (oral or others) 11. Pregnant patients 12. Lactating patients 13. Patients with a past history of anaphylactoid reaction 14. Patients with a past history of bronchial asthma or any other allergic disorder 15. Patients with a past history for a lower threshold of seizures 16. Patients with a past history for a lower threshold of seizures 17. Patients with a past history of severe cardiovascular disease 18. Patients with a past history or evidence of moderate or severe renal failure (GFR < 60ml/min) 19. Any patient presenting with a known contra-indication for MR scanning, for example: a. Cardiac or cerebral pacemaker b. Iron containing surgical implants c. Cochlear implants d. Intracerebral or intraocular iron-containing foreign bodies 20. Non-compliant or uncooperative patients with regard to study protocol 21. Patients having previously been included in this study 22. Patients already participating in another ongoing diagnostic or therapeutic study 23. Patients non-eligible for social benefits 24. Patients under guardianship 25. Patients not having given their written consent to participate in this study 26. Any patient with an accompanying systemic disease, cardiac disease or mental disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our primary objective is to address in clinically isolated syndromes (CIS) patients at high risk of developing MS and early clinical deficit a key question of autoimmune neuroinflammation: By performing Gd- and USPIO MRI studies to explore the predictive value of USPIO with regard to the conversion rate from CIS to MS, but also to predict a more severe clinical MS course – its implication at baseline and at follow-up. ;Secondary Objective: Secondary measures of this study will include comparison of the USPIO (SH U 555 C) findings with other highly sensitive, but non-specific MR parameters.;Primary end point(s): Primary outcomes: • USPIO enhancing MS lesion at baseline as a predictor for a higher risk to develop a second clinical event (time to second clinical event) in monosymptomatic CIS patients (evidence of USPIO enhancement: yes/no; and number of USPIO lesions). • USPIO and/or Gadolinium enhancing MS lesions as a predictor for a higher risk to develop a second clinical event (time to second clinical event) in monosymptomatic CIS patients (evidence of USPIO or Gd enhancement: yes/no; and number of USPIO and/or Gd lesions) | — |
Countries
France
Outcome results
None listed