Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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