Neuroimmunology & Neuromuscular Clinical Trials
University Hospitals Leads Clinical Research Studies Exploring Neuromuscular Diseases
Advanced research and clinical trials are a key component of the Neuromuscular Center’s mission at University Hospitals Neurological Institute. Our physician-researchers are involved in a variety of investigations, each with the potential to improve diagnosis and treatment.
- CIELO Study
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A Phase III, Randomized, Double-blind, Placebocontrolled, Multicenter Basket Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Anti N-methyl-d-aspartic Acid Receptor (Nmdar) Or Anti Leucine-rich Glioma-inactivated 1 (Lgi1) Encephalitis
The purpose of this study is to assess the effects, good or bad, of an investigational treatment in participants with autoimmune encephalitis. In the study, half of the participants will receive an investigational treatment, and the other half will receive a placebo. This investigational treatment is in addition to the continuation or completion of standard therapy for autoimmune encephalitis. The effects will be compared between those who receive investigational treatment and those who receive placebo. A placebo looks exactly like the study drug but has no active ingredient.
- SPHERES Study
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Synergy of Prospective Health & Experimental Research for Emerging Solutions Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Principal Investigator: Dr. Hesham Abboud
Study Purpose: The purpose of this registry study is to learn more about NMOSD, how doctors treat NMOSD, how well medications and other treatments work, the safety of those treatments, and to improve the care and outcomes of people with NMOSD. Approximately 800 male and female subjects in America are expected to participate in this registry study.
Basic Eligibility Criteria:
- Participants must be 18 years of age or older inclusive
- Must have a previous diagnosis of NMOSD according to the 2015 IPND consensus diagnostic criteria for NMOSD.
Study Coordinators:
- Eileen Terrell Eileen.Terrell@UHhospitals.org,
- Madelyn Pierce Moberg Madelyn.Moberg@UHhospitals.org
- ABC/IBM Study
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A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
Principal Investigator: Christopher D. Geiger, MD
Study Purpose: This study is being conducted to determine the efficacy, safety and tolerability of subcutaneous (SC) dosing of ABC008 in subjects with inclusion body myositis (IBM).
Basic Eligibility Criteria:
- Participant must be 40 years of age or older inclusive
- Weight is greater than or equal to 40kg but no more than 115kg.
- Diagnosis of either clinic-pathology defined IBM, clinically defined IBM, or probable IBM (Rose et al 2013).
- Able to arise from a chair without support from another person or device.
- Able to ambulate at least 20ft/6meters (may use walking supports for walk)
Study Coordinators:
- Eileen Terrell Eileen.Terrell@UHhospitals.org
- Madelyn Pierce Moberg Madelyn.Moberg@UHhospitals.org
- Post COVID POTS
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A phase 2 randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of efgartigimod IV in adult patients with post–COVID-19 postural orthostatic tachycardia syndrome (POTS).
This study is examining the safety of an investigational drug in people with POST COVID-19 postural orthostatic tachycardia syndrome (POTS) and how well people tolerate it. It is also looking at how well the study drug works and is processed in people who have post-COVID-19 POST COVID-19 POTS.