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Clinical Research

Enroll HD is a longitudinal, observational, multinational study that will integrate two existing Huntington’s Disease registries, REGISTRY in Europe and COHORT in North America and Australia, while also expanding to include sites in Latin America and Asia. The goal is the build a large and...

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This Phase 3, multi center, open-label study will assess the long-term safety of continuous infusion apomorphine in advanced Parkinson’s disease (PD) patients who are unable to achieve adequate control despite optimized noninvasive therapy. Further, this study will assess the clinical effectiveness of continuous infusion apomorphine...

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This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate the safety, tolerability and efficacy of DA-9805 at 45mg, 90mg versus placebo in subjects diagnosed with early Parkinson’s disease. Parkinson’s disease (PD) is recognized as one of the most common neurologic disorders, affecting...

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The purpose of this program is to create a postmortem (after death) tissue bank of spinal cord, muscle, and brain tissue samples from both amyotrophic lateral sclerosis (ALS) patients and those without the disease (control subjects). Tissue donation provides an important and vital resource toward...

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The purpose of this study is to determine whether magnetic resonance imaging (MRI) cytography (a type of noninvasive 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...

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The Lysosomal Storage Disorders (LSD) Registry Program is a multicenter, international, observational program for people with certain rare diseases. It is designed to track the natural history and outcomes of patients. Currently, patients diagnosed with Pompe disease may participate in this registry program. No experimental...

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FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability....

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The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer’s disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to...

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The main objective of this research project is to provide a comprehensive clinical database of patients with Alzheimer’s disease (AD) and other forms of dementia, individuals with mild cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to identify cognitively normal individuals...

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Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, taken orally once daily. Duration of treatment is 48 weeks. There is also a screening period of up...

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This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection...

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The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of...

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To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced subjects with Parkinson’s disease (PD) who have motor fluctuations. This is a multicenter, randomized, double-blind, double-dummy, active-controlled,...

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A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB).

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The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with multiple system atrophy.

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The purpose of this study is to compare the efficacy of Troriluzole (200mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).

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This is a multicenter, randomized, double-blind, placebo-controlled, three-arm parallel group study to evaluate the efficacy, safety, and pharmacokinetics (PK) of pridopidine versus placebo for the treatment of Levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease.

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A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and snOH with up to 4 weeks of treatment. A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate efficacy, safety,...

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The purpose of the Parkinson’s disease Registry is to develop a national and international database of persons with Parkinson’s disease (PD). The Registry will be used to facilitate the development of new therapies and healthcare services to improve the quality of life for people with...

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This is an observational, multicenter, longitudinal cohort study to characterize adults with Down syndrome ages 25 years and above enrolled at specialized care centers. The aim is to assess changes in cognition, behavior, function, and health over approximately 24 months. Blood will be collected for...

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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...

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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...

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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...

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The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer’s disease rating scale (iADRS).

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Huntington’s disease (HD) is a rare, inherited and progressive neurodegenerative disorder for which hallmark symptoms include movement disorders, loss of cognitive faculties and psychiatric disturbances. With the progression of the disease, patients require increasing level of medical care, caregiver support, and long-term care, which lead...

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This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson’s Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day. This is a 16-week, randomized, phase II, parallel-group,...

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Diagnosing Parkinson’s disease (PD) depends on the clinical history of the patient and the patient’s response to specific treatments such as levodopa. Unfortunately, a definitive diagnosis of PD is still limited to post-mortem evaluation of brain tissues. Furthermore, diagnosis of idiopathic PD is even more...

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Parkinson’s disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety,...

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Patient Experiences with Parkinson’s Disease Treatments: A Mixed-Methods Study.

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Registry for the advancement of DBS in Parkinson’s disease.

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Blinded comparison of different alpha-synuclein seeding assays as cutaneous biomarkers of Lewy body dementias. Beach-NIH/R01 (NS118669-01).

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The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson’s Disease (PD) genes to people with Parkinson’s Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and...

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PPMI 2.0 is a broad program, expanding the goals of the original PPMI study (NCT01141023), that includes this PPMI 2.0 Clinical protocol, as well as the PPMI 2.0 Remote, PPMI 2.0 Digital Applications and PPMI 2.0 Online protocols. All participants in PPMI 2.0 will be...

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The purpose of this platform trial is to evaluate the efficacy of multiple study drugs at once, as compared with placebo, on ALS disease progression. New treatment regimens (drugs) will be added as they become available within the trial, meaning that multiple drug treatment regimens...

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Full Study Name: A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson’s Disease (ENLITE PD – NN110) Description: The ENLITE PD – NN110 study is a 16-week, phase II, multi-center, randomized, parallel-group, dose-selection trial of light therapy in participants with Parkinson’s Disease...

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Alzheimer’s disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis. JNJ-63733657 is a humanized monoclonal anti-tau antibody which...

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This is a phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 administered intravenously in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene. Full Name: A Phase 3 Study to Evaluate Efficacy...

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The primary objective is to evaluate the long-term safety and tolerability of aducanumab after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants). Full Name:...

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A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer’s Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory) The purpose of this study is to evaluate the safety,...

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Barrow Neurological Institute Database for Spontaneous Intracranial Hypotension The purpose of this study is to create a database of clinical features and imaging data from patients seen at Barrow Neurological Institute (BNI) with a diagnosis of spontaneous intracranial hypotension (SIH). The database will help determine...

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Quantitative Analysis of Thecal Sac Volume and Morphology as a Diagnostic Tool in Intracranial Hypotension The purpose of this study is to test the effectiveness of a new imaging tool to increase the confidence in diagnosis of spontaneous intracranial hypotension (SIH). SIH is a condition...

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Preventive Treatment of Migraine: Outcomes for Patients in Real-World Healthcare Systems (TRIUMPH) The purpose of this study is to collect information about treatment patterns, effects, and outcomes in patients with migraine who are switching or initiating a pharmacologic treatment for migraine prevention.  We anticipate that approximately 6000 patients will...

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An “ischemic” stroke is an injury to the brain caused by a blocked blood vessel supplying the brain. Known causes of stroke include a narrowing of a large blood vessel supplying the brain, an abnormal heart beat rhythm, or blockage of a single very small...

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This is a research study looking to compare the effects (good and bad) of the ARCADIA study drugs (apixaban and aspirin) on the occurrence of silent strokes and memory loss after stroke. Your participation is entirely voluntary. This add-on study to the ARCADIA trial involves cognitive testing...

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This research is being done to figure out whether treatment for sleep apnea, in people who have had a stroke or TIA, improves recovery from stroke, and helps prevent future stroke, heart problems, and death. The intervention being tested is called continuous positive airway pressure...

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StATins Use in intRacereberal hemorrhage patieNts (SATURN) This research is being done to find out if it is better to continue or discontinue statin drugs in people who had a brain hemorrhage while taking a statin drug. Statin drugs help prevent heart disease and ischemic...

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction This is a Phase 3 study, which means that BIIB093 (study drug) has already been investigated in previous clinical research studies...

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Phase 2A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis The purpose of this study is to evaluate the safety and tolerability of ANX005, which is a monoclonal antibody that is being developed to treat ALS in adult...

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Efficacy and Safety Study of Oral Edaravone Administered to Subjects with ALS The purpose of this trial is to evaluate and compare the efficacy, safety, tolerability, and changes in nerve conduction tests of 2 different dosing regimens of oral edaravone (study drug) in participants with...

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A Phase 3, Multi-Center, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with ALS The purpose of this trial is to evaluate the effect of reldesemtiv (study drug) v. placebo on ALSFRS-R, FVC, quality of life scales, muscle and...

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A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults with ALS The purpose of this trial is to determine the safety and tolerability of multiple doses of AT-1501 (study drug) in participants with ALS. Additionally,...

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Long-Term, Observational, Registry of Patients with Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies This is a registry study that focuses on patients with Myasthenia Gravis (MG) who have used complement inhibitors. Soliris is an example of this type of medication....

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A Multi-Center, Longitudinal Study of the Natural History of Subjects with Limb Girdle Muscular Dystrophy (LGMD) Type 2E (LGMD2E/R4), Type 2D (LGMD2D/R3), and Type 2C (LGMD2C/R5) The purpose of this study is to learn about the natural progression of LGMD sarcoglycanopathies (types 2E, 2D, and...

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Reliability Studies of Multipoint Incremental MUNE in the Lower Extremities The purpose of this study is to evaluate the application of multipoint incremental motor unit number estimate (MIMUNE), an electromyography (EMG) technique, in 2 distinct muscles of the leg called the extensor digitorum brevis and...

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Electrical Impedance Myography Technology for Quantitative, At-home Muscle Assessment in Amyotrophic Lateral Sclerosis (EIM-At-Home) This research is being performed to evaluate the reliability and ease of use of the improved mScan™ EIM (electrical impedance myography) device as a potential biomarker for ALS for patients to...

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Lysosomal Storage Disorders (LSD) Registry Program – Pompe Registry 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...

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Phase 1/2, Dose-escalation Study to Evaluate the Safety, Tolerability and Efficacy of a Single Intravenous Infusion of SPK-3006 in Adults with Late-onset Pompe Disease The purpose of this study is to evaluate the safety, tolerability, and efficacy of SPK-3006, which is a novel investigational gene...

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Target ALS Biomarker Study: Longitudinal Biofluids, Clinical Measures, and At-Home Measures The purpose of this study is to generate a biorepository of longitudinal blood (plasma and serum), cerebral spinal fluid (CSF), and urine linked to genetics and clinical information that are then made available to...

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What is the purpose of the study? The purpose of this study is to see whether at-home measurements are dependable and can help with tracking disease progression.  What procedures will I participate in if I choose to enroll in the study? You will be required...

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Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic cluster headache. The purpose of this study is to evaluate the efficacy of eptinezumab inpatients with cluster headache. We anticipate that approximately 304 patients will participate...

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A multicenter, randomized, double-blinded, placebo controlled, parallel group, single-dose design to determine the efficacy and safety of nerinetide in participants with acute ischemic stroke undergoing dndovascular thrombectomy excluding thrombolysis The purpose of this study is to evaluate the efficacy and safety of Nerinetide in patients...

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Simulator-based training program for improving driving skills in patients with multiple sclerosis: a phase II proof-of concept pilot study. The primary aim of this study is to assess the effectiveness of a speed of processing training program conducted in a driving simulator in improving speed...

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What is the FASTEST Trial?  Barrow Neurological Institute is conducting a research study of the emergency treatment of patients with bleeding in the brain, also called intracerebral hemorrhage. Barrow Neurological Institute has joined a partnership of over 100 other hospitals and mobile stroke units across North...

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