Date: 2015-09-10
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Medicinova (USA - CA)
Product: MN-166 (ibudilast)
Action
mechanism: phosphodiesterase 4 inhibitor/phosphodiesterase 10 inhibitor/protein inhibitor. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast\'s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive multiple sclerosis and amyotrophic lateral sclerosis (ALS)), substance abuse/addiction and chronic neuropathic pain. MN-166 has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed MN-166 (ibudilast) from Kyorin Pharmaceutical Co., Ltd. for potential utility in relapse-remitting multiple sclerosis (RRMS). Intellectual property was additionally established or obtained by MediciNova in progressive MS and other neurological conditions.
Disease: amyotrophic lateral sclerosis
Therapeutic area: Neurodegenerative diseases - Rare diseases
Country: USA
Trial
details: This is a single-center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical endpoint responsiveness of MN-166 (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in subjects with ALS. The protocol amendment plans for an additional 60 advanced ALS patients, who are on NIV support, to be enrolled in the study. This study consists of two treatment arms, MN-166 and matching placebo, and randomization will occur in a 2:1 ratio (MN-166: placebo). To be eligible, subjects must have a diagnosis of sporadic or familial ALS with onset of less than 10 years from first clinical weakness prior to screening, may be on NIV support, and must be on a stable dose of riluzole for at least 1 month prior to study drug treatment. A total of approximately 120 male and female subjects from 18 to 80 years old, inclusive, will be enrolled (80 subjects in the MN-166 group; 40 subjects in the placebo group). Upon completion of the Double-blind Phase, subjects randomized to the placebo arm will continue for an additional 6 months and will receive open-label MN-166. If there are no safety or tolerability concerns in the MN-166-treated group, a decision will be made to extend participation to the MN-166-treated group into the Open-Label Extension (OLE) Phase. Otherwise, only the placebo-treated patients will participate in the OLE Phase. The primary objective is to evaluate the safety and tolerability of MN-166 60 mg/day versus placebo when administered for 6 months with riluzole. The secondary objective is to evaluate the clinical endpoint responsiveness of MN-166 60 mg/day versus placebo when administered with riluzole as measured by the following assessments: Functional activity as assessed by the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R), Respiratory function as measured by slow vital capacity (SVC), Maximum Inspiratory Pressure (MIP) also known as Negative Inspiratory Force (NIF) and Forced Expiratory Volume in 1 second (FEV1) measured under SVC protocol, Muscle strength measured by manual muscle testing (MMT) and instrumented hand grip dynamometry. (NCT02238626)
Latest
news: * On September 2, 2015, MediciNova announced that the first advanced amyotrophic lateral sclerosis patient, using non-invasive ventilation (NIV), has enrolled in the Phase 2 clinical trial evaluating MN-166 (ibudilast) in both early and advanced stage ALS. MediciNova amended the protocol to expand its recruitment to include advanced ALS patients in the trial, and this amendment was approved by FDA. The amended protocol now plans enrollment of 60 advanced ALS patients with NIV support in the study in addition to 60 patients without NIV support. Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System\'s Neuromuscular/ALS-MDA Center, is the Principal Investigator of the study.
