Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS

• Conditions: 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis); MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis; MedDRA version: 9.1Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressive; MedDRA version: 9.1Level: LLTClassification code 10028246Term: Multiple sclerosis aggravated; MedDRA version: 9.1Level: LLTClassification code 10028247Term: Multiple sclerosis like syndrome; MedDRA version: 9.1Level: LLTClassification code 10028248Term: Multiple sclerosis-like syndrome; MedDRA version: 9.1Level: LLTClassification code 10048393Term: Multiple sclerosis relapse; MedDRA version: 9.1Level: LLTClassification code 10053395Term: Progressive multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosis

• Registration Number: EUCTR2007-005363-10-FR
• Lead Sponsor: C.H.U. de RENNES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified