The MIS416 trial is a clinical research trial now enrolling patients with Secondary Progressive Multiple Sclerosis (SPMS) in Australia. Full information about the trial can be viewed by clicking HERE. Please click on the pin nearest to your geographic location to learn more about trial sites in your area.
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Primary Outcome Measures:
- Change from baseline of neuromuscular function at 12 months [ Time Frame: Baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Neuromuscular function will be assessed using the following test:
- MS Function Composite (MSFC), comprising the; timed 25 Foot Walk, 9 Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test (PASAT);
- Jebsen Hand Function Test (JHFT);
- Grip, tip and key pinch strength;
- Symbol digit modalities test (SDMT);
- Sloan low-contrast letter visual acuity (SLCVA);
- 6-minute walk test (6MWT);
- Proportion of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Safety assessments will be conducted at each study visit and include; characterization of the type, incidence, severity, timing, seriousness, and relationship to treatment of adverse events (AEs); effects on vital signs and clinical laboratory parameters; changes on electrocardiograms (ECGs); and at 3 months and 12 months – the number of gadolinium-enhancing lesions on cranial MRI assessments.
Secondary Outcome Measures:
- Change from baseline of disability and health status at 12 months [ Time Frame: Baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Disability and health status will be assessed using the following assessments and patient reported outcomes:
- Expanded Disability Status Scale (EDSS)
- Patient Reported Outcomes (PROs) including;
- SF-36 and its components;
- MS Impact Scale (MSIS-29);
- Neurological Fatigue Index for MS (NFI-MS);
- Brief Pain Inventory (BPI).
- Change from baseline of neurodegeneration by assessing changes in Magnetic Resonance Imaging (MRI) markers at 12 months [ Time Frame: Baseline, 3, and 12 months ] [ Designated as safety issue: No ]
Disease activity and neurodegeneration will be assessing using Magnetic Resonance Imaging (MRI) markers including lesions, whole brain atrophy (WBA) and Magnetization Transfer Ratio (MTR).
- Change from baseline of activity of immune biomarkers in serum [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
The effect on immune biomarkers will include the analysis of serum for some or all of the following markers: IP-10 (CXCL10), MCP-1 (CCL2), MIG (CXCL9), IL-8 (CXCL8), IFNγ, Neopterin, IL-1RA, sTNF-R, IL-12/23, p40, CD62E (E-selectin), CD54 (ICAM-1), and CD106 (VCAM-1).
- Change from baseline of activity of immune biomarkers in cerebrospinal fluid (CSF) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
The effect on immune biomarkers will include the analysis of CSF for some or all of the following markers: IP-10 (CXCL10), MCP-1 (CCL2), MIG (CXCL9), IL-8 (CXCL8), IFNγ, Neopterin, IL-1RA, sTNF-R, IL-12/23, p40, CD62E (E-selectin), CD54 (ICAM-1), and CD106 (VCAM-1).
- Change from baseline in Peripheral Blood Mononuclear Cell (PBMC) immune biomarkers [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Some or all of these biomarkers may be assayed ex vivo: PBMC expression of mRNA encoding proteins involved in myeloid differentiation and immune regulatory function (e.g. VEGF, Arginine, INOS, IL-10, MMP9); PBMC myeloid subset production of IL-10, TGFβ, IL-6, TNFα, IL-1β, IFNγ, IL-17, and GM-CSF in response to stimulation with LPS, LPS/IFNγ or MIS416 ex vivo; and PBMC subset analysis of myeloid and dendritic cell subsets for immunoregulatory cell subset markers.
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