RecruitingMS (type not specified)NCT04106830

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Azathioprine

    Amidophosphoribosyltransferase inhibitor|DNA inhibitor

What it measured

Main measures

  • The brain structural change over time between the baseline MRI and the follow-up MRIs

    On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

    MRI lesionsBrain volume loss
  • The spinal cord change over time between the baseline MRI and the follow-up MRIs.

    On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

    MRI lesions
  • The functional change over time between the baseline MRI and the follow-up MRIs.

    On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

    MRI lesions

Other measures (3)

  • Change from Baseline Expanded Disability Status Scale (EDSS)/ Functional Systems (FS)

    On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

    Disability progression
  • Timed 25-foot Walk

    On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

    Disability progressionWalking and mobility
  • Mean change in visual acuity as assessed by Sloan 2.5% low contrast visual acuity chart.

    On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later

    Vision

Who could take part

MS (type not specified) · 16 to 75

Inclusion Criteria: * 16-75 * Diagnosis of neuroinflammatory and demyelination disease * Availability of demographic and clinical data at the time disease onset * Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years. Exclusion Criteria: * Patients for whom MRI is contra-indicated * Patients included in an ongoing clinical trial where the product is blinded

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

Contact details on the registry

About this trial

In the sponsor's words

CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI. In addition, participants will receive a one-time baseline examination including T1WI, T2WI, FLAIR, and SWI sequences on 7T MRI, as well as PET-MRI.

Papers

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History

    1. Started

      Jan 2019

    2. Main results due

      Dec 2027

    3. Finished

      Dec 2028

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