Clinical Trials Logo

Clinical Trial Summary

In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This new ligand for PBR displays several advantages compared to the existing reference compound PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose metabolism in activated immune cells in the white matter. Progressive MS patients (secondary progressive and primary progressive) will be compared to relapsing-remitting patients and to healthy volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to document clinical disability and tissue injury. A clinical and radiological follow up will then be performed for a 2-year period. This study should help to understand the contribution of the intracerebral inflammation on the progression of disability and could provide a surrogate marker for further therapeutic trials in chronic progressive MS.


Clinical Trial Description

Study design This study is a prospective cross-sectional controlled multicentric clinical study in 45 MS patients and 20 controls. Four groups of person will be included and compared: - Group I: 20 healthy volunteers aging from 18 to 65 years. These healthy volunteers will be matched for age and sex with patients (1/2). - Group II: 15 patients aging from 18 to 65 years with relapsing-remitting (RRMS), with less than 10 years of evolution since the first manifestation and no recent relapse. - Group III: 15 patients aging from 18 to 65 years with secondary progressive MS (SPMS), with less than 10 years of evolution since the occurrence of the secondary progressive phase. - Group III: 15 patients aging from 18 to 65 years with primary progressive MS (PPMS) diagnosed since less than 10 years. Study centres MS patients and the 20 healthy volunteers will be recruited in the Hospital Pitie-Salpetriere MS patients will be recruited in the Hospital Tenon This study will be performed by complementary teams already collaborating on molecular imaging trials in MS (which assess neuronal loss or demyelination/remyelination): i) the "Centre d'Investigation Clinique" (Salpetriere hospital, Paris), which is strongly experienced in the coordination of clinical and translational research on MS; ii) the CENIR (centre for neuroimaging research, Salpetriere hospital, Paris) a specialized MRI centre for research on neurological diseases; iii) the SHFJ (DSV, CEA, ORSAY) which is a world class molecular imaging centre; Study duration Per patient the study will last two years Per control the study will last up to 8 weeks ;


Study Design


Related Conditions & MeSH terms

  • Inflammation
  • Multiple Sclerosis
  • Multiple Sclerosis, Chronic Progressive
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Secondary Progressive
  • Sclerosis

NCT number NCT02305264
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase N/A
Start date March 19, 2012
Completion date September 10, 2018

See also
  Status Clinical Trial Phase
Completed NCT02861014 - A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) Phase 3
Terminated NCT01435993 - Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis Phase 1
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Completed NCT02410200 - Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS Phase 2
Completed NCT03975413 - Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
Completed NCT05080270 - Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis Early Phase 1
Completed NCT01116427 - A Cooperative Clinical Study of Abatacept in Multiple Sclerosis Phase 2
Completed NCT01108887 - An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmartâ„¢. N/A
Completed NCT01141751 - An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy N/A
Completed NCT00097331 - Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis Phase 2
Completed NCT01909492 - Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Completed NCT04121221 - A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS Phase 3
Not yet recruiting NCT05290688 - Cellular microRNA Signatures in Multiple Sclerosis N/A
Withdrawn NCT04880577 - Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis Phase 2
Completed NCT04528121 - Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis N/A
Recruiting NCT04002934 - Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis Phase 2
Recruiting NCT05019248 - Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
Completed NCT04580381 - Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
Completed NCT00071838 - Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis Phase 2