Multiple Sclerosis Clinical Trial
Official title:
Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG)
Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also
includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are
partly independent of lesion formation and relapse activity , but represent the direct
driver of clinical long-term disability and cognitive decline.
Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor
EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and
numerical data which are closely correlated to the EDSS. As EP capture the functional
integrity of the examined systems they represent a method unbiased for directional changes,
while remaining specific for the neuronal function, and hence can measure deterioration, as
well as improvement, a germane advantage to capture drug response.
High-resolution electroencephalography (EEG) allow for explorative analysis of potential
surrogate markers for cognitive decline.
Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment
effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense
lesions as well as on the annualized relapse rate in a recent phase II trial in
relapsing-remitting MS.
The present study will investigate the effects of OCR on multimodal evoked potentials (EP),
Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue
will be explored.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
| Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
| Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
| Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
| Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
| Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
| Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
| Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
| Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|