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MN-166 · IBU-ALS-1201

Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Ensayo de MEDICINOVA INC en Esclerosis lateral amiotrofica.

Más ensayos de: Esclerosis lateral amiotrófica.

Fase

Fase 2

Estado

Completado

Participantes

70

previstos

Centros

1

Fin del objetivo primario

ago 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2014.

Qué mide

Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS (del registro, en inglés) (6 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a single center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS. This study will consist of two treatment arms, MN-166 and matching placebo. Randomization will occur in a 2:1 ratio (MN- 166: placebo). Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months; Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last dose. During treatment phase, subjects return to the clinic at Months 3 and 6 and will be telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new or concomitant medications. All subjects (subjects who complete the Double-blind Phase and subjects who complete the Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately 2 weeks after the last dose of study drug to assess adverse event status and to document concomitant medications. Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional assessments will include regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs, ECGs, medical history, physical and neurological examinations.

Más ensayos de MNOV

Todos los de MNOV, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02238626), actualizada en oct 2021.