Currently Enrolling NMOSD Clinical Trials

Conducting research through clinical trials is one of the ways we develop and identify new therapies and learn what the best treatments are for rare neuro-immune disorders. There are three clinical trials that are currently enrolling patients with neuromyelitis optica spectrum disorder (NMOSD). We have included a summary of all three studies below. For more information on clinical trials, visit http://bit.ly/tma-clinical-trials.

PREVENT Study

Alexion Pharmaceuticals, Inc. is conducting a clinical trial called the PREVENT Study. The primary objective of the study is to assess the efficacy and safety of an investigational medicine as a potential treatment to prevent relapses in NMO and NMO Spectrum Disorder (NMOSD).

This is a randomized double blind study, where participants will receive investigational medication or placebo and neither the participant nor the study doctor or their staff will know who received the drug or placebo. In this study, 2 out of 3 participants will receive investigational medication and 1 out of 3 participants will receive placebo. The medication is given intravenously at the study doctor’s office or infusion center.

Participants may be eligible if they are at least 18 years old, have a positive test for the NMO-IgG antibody and have experienced 2 relapses in the past 12 months or 3 relapses in the last 24 months with at least 1 relapse in the last 12 months.

This is an “add on study,” and patients may be able to continue taking their current NMO or NMOSD medications and receive the study medication.

There are known and unknown potential side effects, which will be discussed prior to enrollment and detailed in the informed consent. For more information, email: clinicaltrials@alxn.com

N-Momentum Study

Medimmune is currently conducting the N-Momentum study, a clinical research trial in subjects with NMOSD. The trial is actively recruiting seropositive and seronegative NMOSD patients around the world. The main objective of this study is to determine if inebilizumab (formally known as MEDI-551) compared to placebo can significantly delay the time it takes for a new NMO/NMOSD attack to occur.  The trial will recruit 252 NMOSD subjects from approximately 100 sites in 25 countries, 67 confirmed adjudicated NMOSD attacks are needed to determine if inebilizumab is effective compare to placebo.

This is a multinational randomized, double-masked, placebo-controlled study with an open‑label period. Eligible NMO/NMOSD patients will be “randomized” in a 3:1 ratio to received either MEDI-551 or placebo. This random selection will give a 25% (1 in 4) chance of getting placebo and a 75% (3 in 4) chance of getting Inebilizumab.

This trial enrolls seronegative and seropositive NMOSD patients. After being enrolled in the study, subjects are followed for 28 weeks in the placebo-controlled treatment period where inebilizumab or placebo will be given by an intravenous infusion on Day 1 and Day 15. During the study, no additional immunosuppressive therapy will be allowed.

Patients will have the option to enroll into the open-label period if a confirmed NMOSD attack occurred during the placebo-controlled treatment period. Subjects who complete the placebo-controlled treatment period without experiencing an attack will also be given the option to enroll in the open-label period. During the open-label period, inebilizumab will be given on Day 1 and Day 15 and then every 6 months thereafter until the end of the study.

As of April of 2017, 141 NMOSD subjects have been enrolled in the study of which 130 are AQP4 seropositives and 11 are AQP4 seronegatives.

If you are interested in participating, please contact: the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or email information.center@astrazeneca.com

SA237 Study

This research is being conducted to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of a humanized anti-human IL-6R neutralizing monoclonal antibody (SA237) in patients with Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD). This study is being conducted in the US and Canada and will enroll seventy (70) patients to participate in this research.

SA237 is a humanized anti-human IL-6R neutralizing monoclonal antibody that was designed by applying recycling antibody technology to the approved anti-IL6 receptor antibody, tocilizumab, which is currently marketed as a treatment for rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and Castleman’s disease. The recycling antibody technology enabled SA237 to bind to IL-6 receptor multiple times and be slowly cleared from plasma, which is expected to contribute to improvement and is convenient with once monthly dosing frequency. The longer plasma half-life of SA237 compared with tocilizumab was confirmed based on the results of a non-clinical study and a Phase 1 study in healthy volunteers.

Individuals who have NMO or NMOSD and are between the ages of 18 and 74 years may be eligible.

If you are interested in participating, please email sa237@chugai-pharm.co.jp

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