This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
The primary objective of this study is to characterize the general safety and tolerability of olesoxime (495 mg, od), compared to placebo when administered in combination with Interferon beta over a 24-week treatment period in patients with stable Relapsing Remitting Multiple Sclerosis. The secondary objective of this study is to evaluate the feasibility of multicenter protocols for measurement of neurodegeneration and remyelination by MRI as well as the plasma exposure to olesoxime (495 mg, od). MRI will be performed to all patients to assess effects of olesoxime on brain inflammation as well as to assess measures of brain atrophy, neuronal damage and myelination status at Baseline, 12 weeks and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit).
placebo capsule shells with identical appearance as the active compound TRO19622
Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612
Marseille, France
CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims
Reims, France
CHU Pontchaillou, Neurology Department
Rennes, France
Safety criteria
Cumulative incidence of adverse events/serious adverse events (i.e. total number per patient) as assessed by ongoing monitoring.
Time frame: The primary endpoint of this study will be the cumulative incidence of AE/SAE assessed by ongoing monitoring at week 24 (day 168)
MRI Parameters
1. Number of Gadolinium-enhancing lesions on T1-weighted images 2. Number of new or enlarged lesions on T2-weighted images
Time frame: Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit)
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