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Research

Washington DC Neurological Clinical Trials

Our neurologists actively participate in clinical trials and have expertise in conducting research in a diverse array of neurological disorders including stroke, epilepsy, myasthenia gravis, peripheral neuropathy, amyotrophic lateral sclerosis, multiple sclerosis and movement disorders.

Our Clinical Research Unit consists of clinical investigators, all with specialty board certifications and faculty appointments at The George Washington University School of Medicine & Health Sciences, a clinical nurse manager, nurse practitioner, research coordinators and research assistants. Our group has combined experience in Phase II, III and IV clinical trials.

Our goal is to promote new understanding in order to alleviate suffering from neurological diseases. We are committed to performing both sponsor-initiated and investigator-initiated clinical trials with the highest standard of scientific rigor and ethical integrity.

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Clinical Trials

  • INSYTE: Management of Parkinson’s Disease Psychosis in Actual Practice (The INSYTE Study)
    The INSYTE Study will examine the current disease progression of Parkinson’s disease Psychosis (PDP), the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers.
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  • REFALS:EFFECTS OF ORAL LEVOSIMENDAN (ODM-109) ON RESPIRATORY FUNCTION IN PATIENTS WITH ALS
    This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale.
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  • PENNANT: A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
    The purpose of the PENNANT study is to evaluate the safety, tolerability, and effectiveness of the study drug (H.P. Acthar Gel®) in slowing the loss of motor skills or brain function in patients with ALS and to assess whether the study drug can increase an ALS patient’s life expectancy. Eligible participants will either receive the study drug or a placebo (inactive drug).
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  • Protocol H8H-MC-LAIJ, Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
    The objective of this Phase 3 study is to evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo.
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  • ARISE: pAdsevonil in drug-ResIStant Epilepsy: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY, PHASE 2
    The primary objectives of this study are to characterize the dose-response relationship with respect to efficacy of PSL administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy and to evaluate the efficacy of the 4 selected dose regimens of PSL compared with placebo. The secondary objective is to assess the safety and tolerability of all doses of PSL in relation to placebo.
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  • A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy
    The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) infusion every 4 weeks reduces the frequency of seizures in adult subjects with drug-resistant focal epilepsy.
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  • Low frequency electrical stimulation of the fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
    To develop a protocol to evaluate the safety and tolerability of low frequency stimulation of the fornix in patients with MTLE.
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