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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR PYRIDOSTIGMINE BROMIDE

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Clinical Trials for Pyridostigmine Bromide

Trial ID Title Status Sponsor Phase Summary
NCT00953914 Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients Completed Hospital de Clinicas de Porto Alegre N/A The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.
NCT01765140 Treatment Use of 3,4-Diaminopyridine Available Vern C. Juel, M.D. N/A This is a continuing project to provide 3,4 diaminopyridine (DAP) under a treatment-use IND to patients with Lambert-Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndrome (CMS).
NCT01855217 Pilot Study on the Pharmacodynamics of Sugammadex in Morbidly Obese Patients: Reversal of Deep Neuromuscular Blockade Unknown status St. Antonius Hospital Phase 3 Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight? To study the pharmacodynamics of sugammadex in morbidly obese patients by comparing 1 mg/kg IBW versus 1 mg/kg TBW versus placebo.
NCT01993680 Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment Active, not recruiting University of Zurich Phase 2 Disabling symptoms of blood pressure dysregulation, impaired swallowing and digestion are common amongst Parkinson`s patients. So far the exact pathophysiology for this is not fully understood. There are results from pathological analyses that the autonomic nervous system is also affected by the accumulation of alpha-Synuclein and that this might even happen in very early stages of the disease process (Qualman et al., 1984; Wakabayashi et al., 1989; Wakabayashi et al., 1990; Bloch et al., 2006). Blood pressure dysregulation is a common autonomic symptom in Parkinson`s patients and treatment - currently most often achieved with Fludrocortisone - often leads to supine hypertension (Plaschke et al., 1998; Braune et al., 1999; Magerkurth et al., 2005). There are studies in patients with autonomic failure that indicate that Pyridostigmine bromide might be an alternative treatment option without causing disabling supine hypertension (Singer et al., 2003; Sandroni et al., 2005; Singer et al., 2006; Yamamoto et al., 2006). Delayed gastric emptying is also an autonomic symptom associated with Parkinson`s disease. By the elevation of the cholinergic tone with Pyridostigmine bromide the investigators also expect to alleviate symptoms of delayed gastric emptying and obstipation, possibly even facilitating the uptake of dopaminergic medication through the gut (Sadjadpour, 1983; Bharucha et al., 2008). Therefore the investigators designed a monocentric randomized, controlled, double blind, crossover phase II trial to show non-inferiority of the effect of pyridostigmine bromide vs. fludrocortisone on symptoms of autonomic dysregulation in Parkinson`s disease.
NCT02206490 Trial of Naltrexone and Dextromethorphan for Gulf War Illness Completed East Carolina University Phase 2 Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments with FDA approved generic drugs are being administered to see if they help with the symptoms of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are dextromethorphan and naltrexone.
NCT02307526 Acetylcholinesterase Inhibition and Orthostatic Hypotension in SC I Unknown status James J. Peters Veterans Affairs Medical Center Phase 2 Due to de-centralized cardiovascular control, persons with spinal cord injury (SCI) experience blood pressure (BP) dysregulation which manifests in chronic hypotension with exacerbation during orthostatic positioning. Although many individuals with SCI remain asymptomatic to hypotension and orthostatic hypotension (OH), we recently reported reduced memory and marginally reduced attention and processing speed in hypotensive individuals with SCI compared to a normotensive cohort. Thus, we believe that treatment of overtly asymptomatic hypotension and OH in the SCI population is clinically warranted. Currently the FDA has approved only midodrine hydrochloride for the treatment of dizziness associated with OH and proof of efficacy is limited. Acetylcholinesterase inhibition for treatment of OH is a novel concept and has gained recent recognition in models of neurogenic OH (multiple system atrophy; pure autonomic failure, diabetic neuropathy). The physiological rationale of this concept is unique: acetylcholine (AcH) is the pre-ganglionic neurotransmitter of the sympathetic nervous system. Inhibition of acetylcholinesterase will limit the breakdown of AcH thereby facilitating vascular adrenergic tone and peripheral vasoconstriction. Acetylcholinesterase inhibition has been reported to be efficacious in models of both pre-ganglionic (multiple system atrophy) and post-ganglionic (pure autonomic failure, diabetic neuropathy) origin and persons with SCI reflect a model of a preganglionic disorder. In theory, if an individual has a complete autonomic lesion, acetylcholinesterase inhibition would not be expected to improve orthostatic BP because little/no neural traffic would be transmitted to the pre-synapse. However, individuals with an incomplete autonomic lesion may benefit from this class of agent. Researchers are currently investigating the orthostatic BP effects of acetylcholinesterase inhibition with pyridostigmine bromide (60 mg) in 10 individuals with complete (AIS A) and 10 individuals with incomplete (AIS B, C, & D) SCI.
NCT02850276 Autonomic Neuropathy, GI Motility, and Inflammation in HIV Recruiting National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 0 The purpose of this study is to explore a possible link between the autonomic nervous system and immune function in patients with HIV. Sometimes HIV can cause these nerves to function abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a condition that is different from person to person. In some people it causes no symptoms and is not harmful, in others it may cause symptoms such as dizziness or lightheadedness, nausea, vomiting, diarrhea, constipation, or problems urinating. Most people with HIV-AN don't know that they have it. One of the important nerves in the autonomic nervous system is the vagus nerve. Abnormal function of the vagus nerve may cause stomach and intestinal slowing, which could lead to an overgrowth of bacteria. The body senses these bacteria and tries to fight them, leading to inflammation. In this study the researchers will test whether abnormal function of the vagus nerve in HIV is associated with stomach slowing and overgrowth of bacteria, and if a drug called pyridostigmine can help.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pyridostigmine Bromide

Condition Name

Condition Name for Pyridostigmine Bromide
Intervention Trials
Immune Deficiency 1
Autonomic Disturbances in Parkinson`s Disease 1
Hypotension, Postural 1
Postural Tachycardia Syndrome 1
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Condition MeSH

Condition MeSH for Pyridostigmine Bromide
Intervention Trials
HIV Infections 2
Acquired Immunodeficiency Syndrome 2
Parkinson Disease 1
Postural Orthostatic Tachycardia Syndrome 1
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Clinical Trial Locations for Pyridostigmine Bromide

Trials by Country

Trials by Country for Pyridostigmine Bromide
Location Trials
United States 5
Netherlands 1
Mexico 1
Brazil 1
Switzerland 1
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Trials by US State

Trials by US State for Pyridostigmine Bromide
Location Trials
North Carolina 2
Tennessee 1
New York 1
New Jersey 1
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Clinical Trial Progress for Pyridostigmine Bromide

Clinical Trial Phase

Clinical Trial Phase for Pyridostigmine Bromide
Clinical Trial Phase Trials
Phase 3 1
Phase 2 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Pyridostigmine Bromide
Clinical Trial Phase Trials
Active, not recruiting 2
Unknown status 2
Completed 2
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Clinical Trial Sponsors for Pyridostigmine Bromide

Sponsor Name

Sponsor Name for Pyridostigmine Bromide
Sponsor Trials
East Carolina University 1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 1
University of Zurich 1
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Sponsor Type

Sponsor Type for Pyridostigmine Bromide
Sponsor Trials
Other 8
NIH 2
U.S. Fed 1
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