Table 3.

Endpoints and Measures.

Endpoints	Measure
Primary Endpoint
Whole Brain Atrophy (WBA)	Brain parenchymal fraction (BPF) analysis by MRI
Main Secondary Endpoints
Diffusion Tensor Imaging (DTI)	DTI in descending pyramidal tracts
Magnetization Transfer Ratio (MTR)	MTR in the normal-appearing brain tissue
Optical Coherence Tomography (OCT)	Mean peripapillary retinal nerve fiber layer thickness
Cortical atrophy	Cortical Longitudinal Atrophy Detection Algorithm
Additional Secondary Endpoints
Inflammatory Disease Activity	T1 lesion volume T2 lesion volume Annualized relapse rate
Disability	Expanded Disability Status Scale (EDSS) Multiple Sclerosis Functional Composite (MSFC)
Cognitive Impairment	Symbol Digit Modalities Test Selective Reminding Test
Quality of Life	Multiple Sclerosis Impact Scale (MSIS-29) EuroQol 5 Dimensions (EQ-5D), Short Form-36 Health Survey (SF-36)
Neuropathic Pain	Brief Pain Inventory (BPI)
Tertiary Endpoints
Activity of Ibudilast at 48 weeks	DTI in descending pyramidal tracts MTR imaging in normal-appearing brain tissue RNFL measured by OCT CLADA – measure cortical atrophy
Activity of Ibudilast at 96 weeks	Whole brain gray matter fraction MTR in gray matter New T1 and T2 lesions since baseline