A Global Center for Excellence
Austin Neuromuscular Center is at the forefront of neuromuscular research and clinical trials at the national and international level.
Since 2015, we have achieved major milestones including the first patient enrollment in multiple trials. Our involvement has grown significantly alongside our evolving experience and high quality research. To meet burgeoning demands, we officially established the National Neuromuscular Research Institute in 2021.
National Neuromuscular Research Institute is a global center for excellence in neuromuscular medicine, committed to research and clinical advancement for neuromuscular disorders.
The institute is equipped with a dedicated research infusion suite, lab, and pharmacy. We have a team of highly trained clinical research coordinators and quality control officers on-site. All Austin Neuromuscular Center providers serve as part of the study investigator team.
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Clinical Trial FAQs
Clinical Research is a scientific process used by physicians and scientists and other individuals, through guided, experimental clinical trials to develop and/or improve medicine, treat, better understand, and diagnose disease. It can provide an alternative treatment for people who have a disease with limited options.
Study trials (protocols) are based on patient safety first. Most if not all clinical trials are regulated by the FDA and Institutional Review Board (IRB). These organizations have strict guidelines to determine if a study is safe for humans to participate. Typically, the IRB board consists of a group of people such as physicians, scientists, attorneys, and laymen who meet to review the risks and benefits of a protocol before it is out for public knowledge. If the benefits weigh higher than the risks, the study (protocol) is approved.
Pharmaceutical and biopharma companies, government agencies and other organizations can sponsor a clinical trial for physician practices, hospitals, universities to be a participating site.
A participating site must have qualified staff trained in understanding research guidelines through Good Clinical Practice (GCP) compliance. The research team consists of the physician aka principal investigator (PI) and clinical research coordinators. The PI has oversight of the study and team at the site, while the coordinators (CRC), help organize, maintain records, and conduct the study with the PI.
Most studies are monitored or audited by a third-party company called a Clinical Research Organization (CRO), who is hired by the Sponsor to perform monthly quality assurance checks and visit the site often. Monitors help organize all the supplies, training and communication between the sponsor and the site.
Clinical Research is essential and beneficial in helping discover new treatments for disease. People who participate in studies are screened to qualify to enter the study. If they agree to participate, they must sign a consent form. A study is voluntary, and a patient can withdraw at any time.
Not only do clinical trials improve and develop medicine, but they also potentially offer a better-quality life for people affected by disease.
Active Clinical Trials
- 233AS303 – A Phase 3 Randomized, Placebo-Controlled Trial with a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults with a Confirmed Superoxide Dismutase 1 Mutation. NCT04856982
- PrecisionMed Protocol 4800 – A single or multiple visit protocol for collection of DNA/RNA/SERUM/PLASMA/CSF in Amyotrophic Lateral Sclerosis and related disorders. NCT05349721
- PTC857-CNS-001-ALS – A Phase 2, randomized, double-blind, placebo controlled, parallel study to assess the efficacy, safety, tolerability, pk, and biomarker effects of PTC857 in adult subjects with Amyotrophic Lateral Sclerosis (Cardinals). NCT05349721
- 80202135CDP3001 – Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). NCT05327114
- IMVT-1401-2401 – A Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with active CIDP. NCT05581199
- PVT-2201-301 – A Phase 3 Study to Investigate the Efficacy and Safety of Brepocitinib in Adults with Dermatomyositis (VALOR). NCT05437263
- MS200569_0041 – A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care. NCT05650567
- ARGX-113-2007 – A Phase 2/3, Randomized, Double-Blinded, Placebo Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy. NCT05523167
- ABC008-IBM-201 – A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body MyositisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis. NCT05721573
- VIB0551.P3.S1 – A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period To Evaluate The Efficacy And Safety Of Inebilizumab In Adults With Myasthenia Gravis. NCT04524273
- R3918-MG-2018 – Efficacy And Safety Of Pozelimab And Cemdisiran Combination Therapy In Patients With Symptomatic Generalized Myasthenia Gravis. NCT05070858
- IMVT – 1401-3101 – A Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis. NCT05403541
Participate in a clinical research trial.Interested in participating in a clinical research trial? Submit the form below to get started.
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