The Inflammatory Process and the Medical Imaging in Patients With an I

Early Neuroinflammatory Changes as a Prognostic Marker in Clinically Isolated Syndromes Patients.

Stopped earlyPhase 2Early (CIS/RIS)NCT015675532007-005363-10

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: terminated ( Halted prematurely,expiration of investigationnal product)

What was tested

Treatment tested

  • USPIO MRI - Gadolinium MRI
  • ZK 132 281

What it measured

Main measures

  • ▪ Change in USPIO enhancing MS lesion

    Change from baseline in USPIO enhancing MS lesion at 12 months after the first event of the disease

    MRI lesions

  • Primary outcomes:

Other measures (3)

  • Comparison of primary outcome measures with clinical outcomes and role of USPIO

    at 12 months after the first event of the disease

    Disability progressionBlood or spinal fluid markers

  • Relationship of USPIO (SH U 555 C) enhancing MRI lesions with other MR parameters

    at 12 months after the first event of the disease

    MRI lesionsBrain volume lossMyelin repair

  • Change in USPIO and/or Gadolinium enhancing MS lesions (primary outcome measure)

    Change from baseline in USPIO and/or Gadolinium enhancing MS lesions at 3 years after the first event of the disease

    MRI lesions

Who could take part

Early (CIS/RIS) · 18 to 45 · EDSS 0 to 5

Show the full criteria

Inclusion criteria

* Age between 18 and 45 years * Patients with a first episode suggestive of MS (monofocal or multifocal) * Presence of a first neurologic event suggestive of MS that lasted for at least 24 hours * Patients with a spatial dissemination criteria according to the Mc Donald diagnostic criteria * With an Expanded Disability Status Scale (EDSS) score at baseline between 0 and 5 * USPIO (SH U 555 C) injection has to be performed within 3 months after start of clinical event * Patients have to be in-patients for a minimum of 24 hours after the first USPIO (SH U 555 C) injection * Patients with positive or negative USPIO-MRI during screening are included * Patients must be compliant with study protocol * Patients must have given their written consent to participate in this study

Exclusion criteria

* Any CIS patients having received steroid treatment before acquisition of the baseline USPIO MR scan * Patients in whom any disease other than MS could explain their signs and symptoms, * Patients with complete transverse myelitis or bilateral optic neuritis will be excluded, * Patients who had received prior immunosuppressive or immunomodulatory treatment will be excluded. * Patients who had received corticoids 30 days before USPIO-RMI * Patients which cannot be in-patients for a minimum of 24 hours after the first USPIO (SH U 555 C) injection * Female patients without efficient contraception (oral or others) Pregnant or lactating patients * Patients with a known allergy to iron particles and/or dextrans * Patients having received in the past 5 months iron oxide particles preceding the MRI examination * Patients with a past history of bronchial asthma or any other allergic disorder * Patients with a past history for a lower threshold of seizures * Any patient presenting with a known contra-indication for MR scanning * Non-compliant or uncooperative patients with regard to study protocol * Patients not having given their written consent to participate in this study * Any patient with an accompanying systemic disease, renal disease, cardiac disease or mental disorder

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

While significant progress has been made on medical imagery in recent years in the individualization of different lesions in the nervous system for demyelination, axonal loss, atrophy, little progress has been made in the specific recognition the inflammatory process. Yet this point is essential since the currently available treatments have a partial impact mainly on the inflammatory component and that many uncertainties remain about the links between inflammation and tissue destruction affecting myelin and axons. The recent discovery of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the opportunity to answer important questions which one can sense that this could have a significant impact on therapeutic drug monitoring of these patients. This study will involve 50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse) from the earliest manifestations of the disease with clinical and MRI scheduled for the first 3 years of their disease.

Papers

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History

  1. Phase changed from Not recorded to phase2

  1. Started

    Apr 2009

  2. Main results due

    Jun 2014

  3. Finished

    Jun 2015

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