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.