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
-
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.
- CIELO Study
-
A Randomized, Double-Blind, Placeco-Controlled, Multicenter, Phase 3, Pivotal Study with an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants with Myelin Oligodendrite Glycoptorein (Mog) Antibody-Associated Disease (Mog-Ad)
Principal Investigator: Hesham Abboud, MD
Study ID#: 2023-01162
Study Purpose:With no approved treatment options for MOG-AD, the cosMOG study aims to understand how well-tolerated and effective an investigational drug called Rozanolixizumab is in people with MOG-AD
Eligibility Criteria:
- Age 18-89 years old at time of signed ICF
- Confirmed diagnosis of MOG-AD
- History of relapsing MOG-AD with at least 1 documents relapse over the last 12 months
- Positive serum MOG Ab test using cell-based assay (CBA) within 6 months prior to randomization
Study Cooordinators:
- Davina Patel Davina.Patel@UHhospitals.org
- Ashley HawkinsAshley.Hawkins2@UHhospitals.org
- SPHERES Study
-
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
- Post COVID POTS
-
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.