MediciNova, Inc. has announced that, as of September 15, 2014, the ongoing Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS) had enrolled 150 of the 250 subjects planned to be enrolled. Enrollment is expected to be completed during the first quarter of 2015.
The study is being funded by the U.S. National Institutes of Health (NIH) and is being conducted by the NeuroNEXT clinical trial network within the National Institute of Neurological Disorders and Stroke (NINDS) at the NIH. The collaboration to perform the study includes 28 academic medical centers, MediciNova and advocacy support from the National Multiple Sclerosis Society. The principal investigator is Robert Fox, M.D., M.S., FAAN, Vice-Chair for Research, Neurological Institute, Cleveland Clinic.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to have completed 60% of the enrollment in this study. We look forward to providing further updates as the study progresses."
About the Progressive MS Trial
The Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28 enrolling clinical sites across the U.S. and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 250 qualifying subjects will be randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of 100 mg/day (i.e., 50 mg twice daily). The progressive MS subjects may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization will be controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study are 1) to evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) to evaluate the safety and tolerability of ibudilast (MN-166) (100 mg/day) versus placebo administered orally in subjects with primary or secondary progressive multiple sclerosis. Secondary measures include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life, and neuropathic pain. Exploratory objectives include pharmacokinetic and biomarker analyses.
About the Cooperative Effort
The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS's Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS' existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for the network is based at Massachusetts General Hospital and the data coordinating center is at University of Iowa. Dr. Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society is providing patient advocate input and trial enrollment awareness. MediciNova holds the trial IND with the FDA Division of Neurology Products and additionally provides scientific and analytical support and drug and placebo supply.
Source: CNN money © 2014 Cable News Network (24/09/14)
The University of Virginia (UVa) Medical Center has joined 27 other hospitals around the country in conducting a series of neurological clinical trials. Specifically, UVa recently enrolled in NeuroNEXT (Network for Excellence in Neuroscience Clinical Trials), which is sponsored by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.
UVa is currently recruiting participants for its Phase 2 Clinical Trial to evaluate the safety, tolerability, and activity of ibudilast in patients with primary- or secondary-progressive multiple sclerosis; they hope to recruit 250 male and female subjects ages 21 to 65 years old who have no prior treatment with long-term multiple sclerosis disease modifying therapy or who are receiving glatiramer acetate or interferon beta treatment. Ibudiblast will be administered in conjuction with glatiramer or interferon beta treatment and compared to a placebo.
Participants will receive placebo or 100 mg/day ibudilast for 96 weeks. Primary outcome measures include brain atrophy over 96 weeks and treatment-emergent adverse events over 36 months. Secondary outcome measures include inflammatory, disability, and quality of life statuses, as well as cognitive impairment and neuropathic pain. The study is projected to end in March 2017 with a primary completion date in December 2016.
Ibudilast is special because it is designed to treat patients with progressive multiple sclerosis, and according to Dr. Myla D. Goldman at UVa’s James Q. Miller Multiple Sclerosis Clinic, current medications have failed to stop or slow progressive multiple sclerosis. Consequently, patients have little relief of their symptoms that gradually worsen over time.
Source: BioNews Texas (19/03/14)