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ibudilast

Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis

Ensayo de MEDICINOVA INC en Multiple Sclerosis, Primary Progressive · Multiple Sclerosis, Secondary Progressive (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

255

previstos

Centros

28

Fin del objetivo primario

may 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en nov 2013.

Qué mide

Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF). (del registro, en inglés) (96 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety, tolerability and activity of ibudilast administered twice daily over a 96 week period in subjects with primary or secondary progressive multiple sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation (IFNβ-1A \[Avonex, Rebif\] or IFNβ-1B \[Betaseron, Extavia\]). Study drug or placebo will be administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive, in two treatment groups. Randomization of subjects will be stratified by disease status (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and immunomodulating therapy status: current use of immunomodulating therapy or no current use of immunomodulating therapy. The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96 weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and evening).

Más ensayos de MNOV

Todos los de MNOV, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01982942), actualizada en jul 2020.