MS
MS
At CIC Neurosciences, we conduct three types of studies: therapeutic studies (both industry-sponsored and academic), and pathophysiological studies aimed at unraveling the fundamental mechanisms of diseases in order to advance our understanding and improve patient care.
Industrial therapeutic studies
Academic therapeutic studies
Pathophysiological Studies
ACUITY
A randomized, double-blind study to evaluate the safety and tolerability of OCS-05 compared with placebo in patients with unilateral acute optic neuritis (AON)
🎯: To compare the safety and tolerability of ACT-01 versus placebo at 6 months in subjects with NORB
✅: Done
TOTEM
Treatment of relapsing-remitting multiple sclerosis (RRMS) with testosterone: potential effects on neuroprotection and remyelination.
🎯: To evaluate the remyelinating and neuroprotective effects of a 54-week course of testosterone treatment in patients with relapsing-remitting MS (RRMS) who are being treated with natalizumab (Tysabri®), fingolimod (Gilenya®), or ocrelizumab (Ocrevus®) based on a composite endpoint combining analysis of thalamic atrophy and diffusion tensor measured by MRI.
📝: Currently being monitored
PERSEUS
A Phase 3, randomized, double-blind study to evaluate the efficacy and safety of SAR442168 compared with placebo in patients with primary progressive multiple sclerosis.
🎯: To determine the efficacy of SAR442168 in delaying the progression of disability in early-stage multiple sclerosis compared with placebo
📝: Currently being monitored
LTS17043
A Phase 3 interventional study to evaluate the long-term safety and tolerability of tolebrutinib in patients with relapsing multiple sclerosis, primary progressive multiple sclerosis, or non-relapsing secondary progressive multiple sclerosis.
🎯: To evaluate the safety and long-term tolerability of tolebrutinib in patients with relapsing-remitting MS (RRMS) and primary progressive MS (PPMS)
📝: Currently being monitored
MOGWAI
A phase III, randomized, double-blind, multicenter, placebo-controlled national trial to evaluate the efficacy of azathioprine in preventing relapses in patients with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Diseases following a first episode.
🎯: To assess whether treatment with azathioprine delays or prevents the onset of a new flare-up following an initial episode of MOGAD, compared with placebo, over the course of the study (3 years).
⏳: Currently being added
IMAGIN DEAL
Multimodal imaging signatures of the biological mechanisms underlying neurodegeneration in multiple sclerosis: long-term predictive value.
🎯: To assess the predictive value of imaging signatures (chronic active lesions, remyelination, and pre-lesional areas) for the progression of neurological disability (EDSS: Expanded Disability Status Scale) between initial enrollment in FLUMATEP, INFLASEP, or SHADOWTEP and enrollment in the current study.
⏳: Currently being added
ENERGYSEP
In vivo investigation of the energy origin of neurodegeneration in multiple sclerosis: a two-year study combining high-field sodium imaging, phosphorus spectroscopy, and diffusion-weighted spectroscopy. The energy origin of neurodegeneration in MS
🎯: The main objective of this project is to explore the relationship between MRI-derived parameters reflecting energy dysregulation in the sensorimotor cortex (SMC) at the start of the study, and MRI-derived neurodegeneration parameters in the SMR after 24 months in patients with RRMS and PPMS compared to healthy volunteers, using a combination of quantitative 23Na MRI, phosphorus spectroscopy (³¹P MRS) and diffusion spectroscopy (DW-MRS), and cortical thickness measurements.
📝: Currently being monitored
SMART IN MS
Early-stage remyelination in multiple sclerosis: a longitudinal PET-MRI study evaluating individual myelin repair profiles and the role of neuroinflammation.
🎯: To define individual remyelination profiles for patients (changes in demyelinated lesion voxels) between baseline and month 6 in the relapsing-remitting and progressive phases of the disease.
⏳: Currently being added
REMYELIKIDS
An Investigation of Cortical Remyelination in Children with Multiple Sclerosis
🎯: To investigate the association between individual cortical myelin repair indices based on RTM in children with MS and cognitive scores on the Symbol Digital Modalities Test (SDMT) at baseline.
⏳: Currently being added
At CIC Neurosciences, we conduct three types of studies: therapeutic studies (both industry-sponsored and academic), and pathophysiological studies aimed at unraveling the fundamental mechanisms of diseases in order to advance our understanding and improve patient care.
Industrial therapeutic studies
ACUITY
A randomized, double-blind study to evaluate the safety and tolerability of OCS-05 compared with placebo in patients with unilateral acute optic neuritis (AON)
🎯: To compare the safety and tolerability of ACT-01 versus placebo at 6 months in subjects with NORB
✅: Done
TOTEM
Treatment of relapsing-remitting multiple sclerosis (RRMS) with testosterone: potential effects on neuroprotection and remyelination.
🎯: To evaluate the remyelinating and neuroprotective effects of a 54-week course of testosterone treatment in patients with relapsing-remitting MS (RRMS) who are being treated with natalizumab (Tysabri®), fingolimod (Gilenya®), or ocrelizumab (Ocrevus®) based on a composite endpoint combining analysis of thalamic atrophy and diffusion tensor measured by MRI.
📝: Currently being monitored
PERSEUS
A Phase 3, randomized, double-blind study to evaluate the efficacy and safety of SAR442168 compared with placebo in patients with primary progressive multiple sclerosis.
🎯: To determine the efficacy of SAR442168 in delaying the progression of disability in early-stage multiple sclerosis compared with placebo
📝: Currently being monitored
LTS17043
A Phase 3 interventional study to evaluate the long-term safety and tolerability of tolebrutinib in patients with relapsing multiple sclerosis, primary progressive multiple sclerosis, or non-relapsing secondary progressive multiple sclerosis.
🎯: To evaluate the safety and long-term tolerability of tolebrutinib in patients with relapsing-remitting MS (RRMS) and primary progressive MS (PPMS)
📝: Currently being monitored
Academic therapeutic studies
MOGWAI
A phase III, randomized, double-blind, multicenter, placebo-controlled national trial to evaluate the efficacy of azathioprine in preventing relapses in patients with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Diseases following a first episode.
🎯: To assess whether treatment with azathioprine delays or prevents the onset of a new flare-up following an initial episode of MOGAD, compared with placebo, over the course of the study (3 years).
⏳: Currently being added
Pathophysiological Studies
IMAGIN DEAL
Multimodal imaging signatures of the biological mechanisms underlying neurodegeneration in multiple sclerosis: long-term predictive value.
🎯: To assess the predictive value of imaging signatures (chronic active lesions, remyelination, and pre-lesional areas) for the progression of neurological disability (EDSS: Expanded Disability Status Scale) between initial enrollment in FLUMATEP, INFLASEP, or SHADOWTEP and enrollment in the current study.
⏳: Currently being added
ENERGYSEP
In vivo investigation of the energy origin of neurodegeneration in multiple sclerosis: a two-year study combining high-field sodium imaging, phosphorus spectroscopy, and diffusion-weighted spectroscopy. The energy origin of neurodegeneration in MS
🎯: The main objective of this project is to explore the relationship between MRI-derived parameters reflecting energy dysregulation in the sensorimotor cortex (SMC) at the start of the study, and MRI-derived neurodegeneration parameters in the SMR after 24 months in patients with RRMS and PPMS compared to healthy volunteers, using a combination of quantitative 23Na MRI, phosphorus spectroscopy (³¹P MRS) and diffusion spectroscopy (DW-MRS), and cortical thickness measurements.
📝: Currently being monitored
SMART IN MS
Early-stage remyelination in multiple sclerosis: a longitudinal PET-MRI study evaluating individual myelin repair profiles and the role of neuroinflammation.
🎯: To define individual remyelination profiles for patients (changes in demyelinated lesion voxels) between baseline and month 6 in the relapsing-remitting and progressive phases of the disease.
⏳: Currently being added
REMYELIKIDS
An Investigation of Cortical Remyelination in Children with Multiple Sclerosis
🎯: To investigate the association between individual cortical myelin repair indices based on RTM in children with MS and cognitive scores on the Symbol Digital Modalities Test (SDMT) at baseline.
⏳: Currently being added