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  • Gregory W. Fulton ALS Center

    ALS and Neuromuscular Disease Experts in Phoenix, Arizona

    ALS Clinical Trials

    Enrolling Interventional ALS Clinical Research Studies

    233AS101 (SOD1)

    Full Study Name: a study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of biib067 administered to adult subjects with amyotrophic lateral sclerosis and confirmed superoxide dismutase 1 mutation

    Description: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BIIB067 in adults with ALS and confirmed superoxide dismutase 1 (SOD1) mutation. BIIB067 will be administered via lumbar punctures over a 24-week treatment period (i.e. 3 loading doses administered approximately once every 2 weeks, followed by 5 maintenance doses administered approximately once every 4 weeks). Overall, participants will be in the research study for about 32 weeks.

    Principal Investigators: Shafeeq Ladha, MD

    Sponsor: Biogen

    Enrollment Contact
    Cassie Nelson
    (602) 406-6606
    [email protected]

    261AS101

    Full Study Name: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults with Amyotrophic Lateral Sclerosis

    Description: The purpose of this study is to evaluate the safety and tolerability of BIIB100 in adults with ALS. There are three in-person visits, including an overnight inpatient hospital stay where the study medication is administered orally at one time point, and one final phone visit required for this study. The trial may last about 7 weeks from the time of screening through the observation period.

    Principal Investigators: Shafeeq Ladha, MD

    Sponsor: Biogen

    Enrollment Contact
    Cassie Nelson
    (602) 406-6606
    [email protected]

    NeuroSense NST001

    Full Study Name: Open Label, Off Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients with ALS

    Description: The purpose of this study is to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability, routine disease progression measures, and change in biomarkers. There are six visits required for this study. These visits will happen at the same time as regularly scheduled visits to the BNI ALS Multidisciplinary Clinic, and will occur approximately every 3 months. Overall, participants may be in the research study for about 15 months.

    Principal Investigators: Jeremy Shefner, MD, PhD

    Sponsor: NeuroSense Therapeutics, Ltd.

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    Enrolling Observational ALS Clinical Research Studies

    Speech Analysis in ALS

    Full Study Name: Speech Analysis in ALS Patients with and without Cognitive Abnormalities: Evaluation of Sensitivity and Disease Progression

    Description: The purpose of this study is to determine whether speech and language measures may be used to detect cognitive changes, such as alterations in memory or thinking, in patients with ALS. By detecting cognitive changes earlier in the ALS disease course, we may be able to implement more tailored clinical trial designs, as well as provide better clinical care to ALS patients. There are five visits required for this study. These visits will happen at the same time as regularly scheduled visits to the BNI ALS Multidisciplinary Clinic, and will occur approximately every 3 months. Participants will also complete speech and language assessments at home each week. Overall, participants may be in the research study for about 12 months.

    Principal Investigators: Jeremy Shefner, MD, PhD; Julie Liss, PhD; Visar Berisha, PhD

    Sponsor: Dignity Health and Arizona State University Collaborative Strategic Initiatives Program 2018

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    REFINE-ALS

    Full Study Name: Radicava (Edaravone) Findings in Biomarkers from ALS

    Description: The purpose of this study is to identify biomarkers to serve as quantifiable measures of Edaravone effects in ALS in those who are initiating clinically prescribed Edaravone treatment for the first time or within one month of consenting. Participants in the study will be followed from enrollment up to 24 weeks after treatment initiation (i.e. 6 treatment cycles).

    Principal Investigator: Shafeeq Ladha, MD

    Sponsor: Mitsubishi Tanabe Pharma America Inc.

    Enrollment Contact
    Brittany Arriola
    (602) 406-4571
    [email protected]

    Tissue Donation Program

    Full Study Name: ALS Post-Mortem Tissue Bank

    Description: The purpose of this program is to create a post-mortem (after death) tissue bank of spinal cord, muscle, and brain tissue samples from both ALS patients and those without the disease (control subjects). Tissue donation provides an important and vital resource toward the advancement of research in ALS and other neurodegenerative diseases. The intention of this tissue bank is to support efforts by the research community, enhance collaborations between clinicians and basic scientists, and collate and share information on how to better understand, prevent, diagnose, and/or treat ALS and other diseases. Participants will provide consent to have their tissues stored at Barrow Neurological Institute for use in current and future research projects.

    Principal Investigator: Robert Bowser, PhD

    Sponsor: Target ALS Foundation

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    Biofluid Biomarkers in ALS

    Full Study Name: Biofluid Biomarker Addition to Post-Mortem Tissue Bank

    Description: The purpose of this repository is to collect, process, and store biospecimens and clinical information pre-mortem (before death), and link this information to post-mortem (after death) tissue samples for current and future research in ALS, motor neuron diseases, and other medical conditions. Participants will complete at least one sample collection visit, which includes blood collection and assessments focused on the measurement of motor neuron and cognitive functions. Additional visits and procedures, such as cerebrospinal fluid (CSF) collection, may be completed, should the participant choose to undergo the optional portions of the study.

    Principal Investigator: Lyle W. Ostrow, MD, PhD

    Site Principal Investigator: Robert Bowser, PhD

    Sponsor: ALS Association and Target ALS

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    BIO3

    Full Study Name: Fluid Biomarkers with Deep Phenotyping in Patients with ALS

    Description: This research study is being performed to provide researchers with clinical information, combined with a wide range of biospecimens, to aid in the identification of biomarkers associated with ALS (what changes are unique to ALS), and to assess therapeutic targets. There will be four clinic visits and three scheduled telephone follow up calls. At each clinic visit, participants will have blood (including DNA and RNA) collected, and will be evaluated with assessment tools focusing on motor neuron and cognitive (memory and thinking) functions. Of the four visits in this study, three will also involve the collection of cerebrospinal fluid (CSF), and two will involve Magnetic Resonance Imaging (MRI) cytography (a type of non-invasive body scan). Overall, participants may be in the research study for about 18 months.

    Principal Investigator: Shafeeq Ladha, MD

    Sponsor: ALS Association

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    MRI3

    Full Study Name: Magnetic Resonance Imaging Cytography in Patients with ALS

    Description: The purpose of this study is to determine whether Magnetic Resonance Imaging (MRI) cytography (a type of non-invasive body scan) is useful in establishing disease severity in individuals with Amyotrophic Lateral Sclerosis (ALS). MRI cytography will be compared to measures typically taken at clinic visits measuring motor neuron and cognitive functions to see if it may be related to disease status. In most cases, participants will attend a one-time clinic visit, though the option of two separate study visits may be available.

    Principal Investigator: Christopher Quarles, PhD

    Sponsor: Flinn Foundation

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    Enrolling Interventional Neuromuscular Clinical Research Studies

    ALXN1210-MG-306

    Full Study Name: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients with Generalized Myasthenia Gravis

    Purpose: The purpose of this study is to evaluate the efficacy and safety of Ravulizumab, which is being developed to treat generalized myasthenia gravis by blocking abnormal complement activity, which is the part of the immune system that fights against infections. Ravulizumab is administered via intravenous infusions over a 26-week treatment period (i.e. 2 loading doses administered approximately once 2 weeks apart, followed by 2 maintenance doses administered approximately 8 weeks apart). In addition to the study drug infusions, participants will complete study visits to assess clinical outcomes on a weekly basis for the first month, then bi-weekly for about two months, and finally monthly for the last three months. Overall, participants will be in the research study for approximately 26 weeks, with the option to continue for up to 2 years in an open label extension study.

    Principal Investigator: Suraj Muley, MD

    Sponsor: Alexion

    Enrollment Contact
    Cassie Nelson
    (602) 406-6606
    [email protected]

    MG0003

    Full Study Name: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis

    Purpose: The purpose of this study is to assess the clinical efficacy, safety and tolerability of Rozanolixizumab, which is a type of antibody that helps breakdown harmful auto-antibodies in generalized myasthenia gravis patients. Rozanolixizumab will be administered through a 30-minute subcutaneous infusion (i.e. a small needle inserted under the skin) every week for 6 weeks, with a two month observation period. Overall, participants may be in the research study for about 19 weeks, with the option to continue for up to about 1 year in an open label extension study.

    Principal Investigator: Suraj Muley, MD

    Sponsor: UCB Biopharma SPRL

    Enrollment Contact
    Cassie Nelson
    (602) 406-6606
    [email protected]

    CIDP 161403

    Full Study Name: A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

    Description: The purpose of this study is to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia as a maintenance therapy to prevent relapse and for the treatment of CIDP. Subjects must be on a stable dosing regimen of IVIG therapy for at least 12 weeks prior to enrollment. For up to the first 8 weeks, subjects will continue to receive their own IVIG treatment at the same dose and frequency as prescribed prior to entry into the study. Then, subjects will be randomized to receive HyQvia administered through a subcutaneous infusion (i.e. a small needle inserted under the skin) every 2, 3, or 4 weeks for a total of 10 to 15 weeks. Overall, participants may be in the research study for about 28 weeks.

    Principal Investigator: Suraj Muley, MD

    Sponsor: Baxalta US Inc. and Baxalta Innovations GmbH

    Enrollment Contact
    Cassie Nelson
    (602) 406-6606
    [email protected]

    Enrolling Observational Neuromuscular Clinical Research Studies

    LSD Registry

    Full Study Name: Lysosomal Storage Disorders (LSD) Registry Program

    Description: The LSD Registry program is a multi-center, international, observational program for patients with certain rare diseases designed to track the natural history and outcomes of patients. Currently, patients diagnosed with Pompe disease may participate in this Registry Program. No experimental intervention is given; thus, a patient will undergo clinical assessments and receive standard of-care treatment as determined by the patient’s physician. Physicians will determine the actual frequency of necessary assessments according to a patient’s individualized need for medical care and routine follow-up.

    Principal Investigator: Shafeeq Ladha, MD

    Sponsor: Genzyme Corporation

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    SPK-GAA-100

    Full Study Name: A Multi-Center, Low Interventional Study with a Retrospective Component in Participants with Late Onset Pompe Disease

    Description: The purpose of this study is to obtain information pertaining to the occurrence of SPK-GAA antibodies and other laboratory measures in participants with Late Onset Pompe Disease (LOPD) on an enzyme replacement therapy regimen. Additionally, this study will collect retrospective laboratory and medically-relevant historic data relating to Pompe disease from participants in hopes to provide a better understanding of LOPD features to improve the design of a future phase 1/2 interventional gene therapy trial. In most cases, participants will attend a one-time clinic visit, though the option of two separate study visits may be available.

    Principal Investigator: Shafeeq Ladha, MD

    Sponsor: Spark Therapeutics

    Enrollment Contact
    Jessie Duncan
    (602) 406-1466
    [email protected]

    SAS Spinraza

    Full Study Name: A Prospective, Multi-Center, Observational Study of the Safety, Tolerability, and Effectiveness of SPINRAZA® (nusinersen) in Adult Patients with Spinal Muscular Atrophy

    Description: This is a longitudinal, observational study of ambulatory and non-ambulatory adult patients with genetically confirmed chromosome 5q Spinal Muscular Atrophy (SMA) to examine the safety, tolerability, and effectiveness of SPINRAZA® (nusinersen) for up to 30 months. This study does not provide SPINRAZA or cover costs associated with standard clinical care. These patients will be treated by their respective physicians according to standard clinical practice. Study visits include standardized assessments of strength and function, and occur at baseline, Day 15, after treatment initiation, Day 30, Day 60, and then at 4-month intervals through Month 30.

    Principal Investigator: Shafeeq Ladha, MD

    Sponsor: Washington University School of Medicine

    Enrollment Contact:
    Jessie Duncan
    (602) 406-1466
    [email protected]

    About Barrow Neurological Institute
    Since our doors opened as a regional specialty center in 1962, we have grown into one of the premier destinations in the world for neurology and neurosurgery. Our experienced, highly skilled, and comprehensive team of neurological specialists can provide you with a complete spectrum of care–from diagnosis through outpatient neurorehabilitation–under one roof. Barrow Neurological Institute: Discover. Educate. Heal.