New Million-Dollar Trial for Multiple Sclerosis Drug

man taking pills

Cleveland Clinic has been selected as the primary investigator in a $11.3 million nationwide study funded primarily by the National Institutes of Health to conduct a trial of the oral drug ibudilast for progressive multiple sclerosis (MS) patients.

The Phase 2 study will enroll patients at 28 clinical sites across the U.S. The trial is designed to evaluate the safety, tolerability and efficacy of ibudilast, which will be given twice daily to patients with progressive MS. This is a placebo-controlled trial with the goal of recruiting over 250 patients.

Potential treatment for patients with progressive MS

“Currently, progressive MS patients do not have any treatments that will alter their long-term disease course, and it is essential we conduct trials to try to identify an effective treatment,” said Robert Fox, M.D., M.S., FAAN, Principal Investigator of the trial and Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. “This trial will not only study a potential treatment for progressive MS, but will further the knowledge of the best methodologies for evaluating therapies. This will lead to researchers being able to create shorter, more effective trials and getting therapies to patients faster.”

Evaluate safety and tolerability using brain parenchymal fraction (BPF)

The primary goal of the study is to evaluate the activity of ibudilast versus placebo at 96 weeks as measured by magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF). The secondary goal is to evaluate the safety and tolerability of ibudilast (100 mg/day) versus placebo administered orally in subjects with progressive multiple sclerosis. A variety of secondary outcomes will evaluate additional advanced imaging measures and will utilize imaging and biomedical engineering expertise at Cleveland Clinic.

Working together to leverage strengths

The clinical trial will be conducted by the NeuroNEXT Network, representing that group’s largest collaborative effort to date.

The NeuroNEXT Network was created to conduct studies of treatments for neurological diseases through large partnerships and collaborations, leveraging the strengths of multiple organizations in the private, public, and non-profit sectors. The network is designed to expand the capability of The National Institute of Neurological Disorders and Stroke (NINDS) to test promising new therapies, increase the efficiency of clinical trials before embarking on larger studies, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders.

The clinical coordinating center for this trial is Massachusetts General Hospital, and the data coordinating center is the University of Iowa.  Dr. Fox and his colleagues at Cleveland Clinic will collaborate with co-investigators at 28 additional academic medical centers in the NeuroNEXT network. The National Multiple Sclerosis Society provides patient advocate input and trial enrollment awareness and has provided additional funding to increase patient access to the trial and increase patient safety.

The trial is expected to require approximately three years for enrollment, treatment, and data analyses. The drug is already approved in Japan for asthma.

More information

  • honestthought

    For those of us who have West Nile Virus- we will be watching with interest

  • TheNew123Yorker

    How can you deveople a pill to cure something that you don’t even the cause of!!!!

    • Shirley Renshaw

      EXACTLY! They can no longer hood wink us. Is this THE PILL that is suppose to replace that a simple minimal evasive CCSVI treatment? I can just imagine the price tag on this baby. Oh …. and the side effects galore. Oh boy … How creepy.

  • Alison
    • Franz Schelling

      Why are MS patients so easily lead down always the same garden path, paved with wickedly expensive drugs, leaving them but one place to get rid of their disease: the cemetery?

  • Alison

    how is this drug expected to prevent the spinal MS lesions more prevalent in PPMS given that concrete post mortem pathology

    shows spinal MS lesions form via physical mechanical ‘tugging’ on the denticulate ligaments of the spinal cord?

  • Carol

    So MediciNova has exclusive patent for this drug, The scientific advisory board for MediciNova is full of doctors that have publicly dismissed CCSVI treatment as a hoax and also these same doctors have direct control over what the MS Society contributes to. This does explain why these doctors have done everything within their power to roadblock and dismiss CCSVI testing and treatment for MS patients. Their self serving interests and financial rewards lie only with drug based treatments whether they work or not

    • Franz Schelling

      The strangest thing is to see an MRI expert, Frederik Barkhof, numbered among those who dismiss all the imaging evidence for the venous origin of the typical instances of MS. How on earth can he reconcile what he says with what he daily sees ?!

      • Shirley Renshaw

        Maybe he is biased? Money does have a great influence.

        • Franz Schelling

          Can bias really blind to venous anatomy, to logical reasoning, even to the the suffering of one’s patients ?

          • Shirley Renshaw

            Certainly looks like that doesn’t it Dr. Schelling? How unfortunate for the patient. How unfortunate for Science.

          • Franz Schelling

            isn’t it curious what can be referred to as science, dear Ms. Shirley Renshaw ?

    • Shirley Renshaw

      Follow the money. So unfortune for those who are being exploited.

  • Shtanto

    The real shame is knowing good science is going unpublished because a select few control all the journals. Obviously these guys can afford to pay them off

    • Franz Schelling

      This ill gotten gain has already ruined to many lives. It won’t pay off for those who made it !

  • larry

    My brother has ms, they give him drugs that cost a fortune . And do nothing but make the drug co rich.they come up with trial after trial years pass by, the doctors make there living and the patiences get worse , some die .there thinking is I went to College to make big money and that’s all they think about,if they came up with cures it would put them out of there won’t be a cure until the government forces them to come out with it sad but true:(.