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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR MUCOMYST

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Clinical Trials for Mucomyst

Trial ID Title Status Sponsor Phase Summary
NCT00028262 Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children. At around 11 to 13 months of age, patients develop slowed head growth, mild brain atrophy (wasting), electroencephalographic (EEG) changes and retinal deterioration, with symptoms worsening over time. The disease results from an enzyme deficiency that causes fatty compounds called ceroid to accumulate in cells. In laboratory experiments, Cystagon has helped remove ceroid from cells of patients with INCL. Children with INCL between 6 months and 3 years of age may be eligible for this study. Participants take Cystagon daily by mouth every 6 hours. They are admitted to the NIH Clinical Center for a 4- to 5-day period every 6 months for the following tests and evaluations: - Review of medical history, including a detailed record of seizures, physical examination, blood tests and clinical photographs. For the initial baseline studies, examinations may also be scheduled with pediatric neurology, ophthalmology and anesthesia services. - Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves, and computers to provide detailed images of the brain without the use of X-rays. The patient lies on a table that slides inside a donut-shaped machine containing a magnetic field. The child requires general anesthesia for the procedure. - Electroretinogram (ERG) measures the function of the retina, the light-sensitive tissue in the back of the eye. To record the flash ERG, a special contact lens is placed on the eye s surface and the eye is stimulated with flashes of light. Infants and very young children require general anesthesia for the procedure. - Visual evoked potential (VEP) measures the function of the visual pathway from the eye to the brain. To record the VEP, five electrodes are placed on the scalp and the eye is stimulated with flashes of light. Infants and very young children must be anesthetized for the procedure. - Electroencephalogram (EEG) measures brain electrical activity, using electrodes placed on the scalp. The test is useful in defining seizures. The child may need to be sedated to keep still during the test. - Skin biopsy A small piece of skin is removed (usually from the upper arm or shoulder) under local anesthetic to grow cells in the laboratory. This procedure is done at the start of the study and is repeated after 1 year if therapy results are promising. Children s condition may improve, stabilize or worsen during this study. Life may be prolonged without significant improvement in quality. The information gained from the study may help scientists develop more potent drugs to treat INCL.
NCT00122018 An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery Completed Abbott Phase 2 Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
NCT00122018 An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery Completed Linda F. Barr, M.D. Phase 2 Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
NCT00131521 Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit Completed The University of Texas Health Science Center at San Antonio N/A This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).
NCT00248625 N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.
NCT00248625 N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure Completed University of Pittsburgh Phase 3 We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Mucomyst

Condition Name

Condition Name for Mucomyst
Intervention Trials
Contrast Induced Nephropathy 4
Acute Liver Failure 2
Pulmonary Embolism 1
Infantile Neronal Ceroid Lipofuscinosis 1
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Condition MeSH

Condition MeSH for Mucomyst
Intervention Trials
Kidney Diseases 6
Liver Failure, Acute 2
Liver Failure 2
Acute Kidney Injury 1
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Clinical Trial Locations for Mucomyst

Trials by Country

Trials by Country for Mucomyst
Location Trials
United States 39
Canada 2
Korea, Republic of 1
United Kingdom 1
Israel 1
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Trials by US State

Trials by US State for Mucomyst
Location Trials
California 5
Virginia 3
Ohio 3
Texas 3
Illinois 2
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Clinical Trial Progress for Mucomyst

Clinical Trial Phase

Clinical Trial Phase for Mucomyst
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Mucomyst
Clinical Trial Phase Trials
Completed 7
Unknown status 5
Recruiting 2
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Clinical Trial Sponsors for Mucomyst

Sponsor Name

Sponsor Name for Mucomyst
Sponsor Trials
VA Office of Research and Development 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
West Virginia University 2
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Sponsor Type

Sponsor Type for Mucomyst
Sponsor Trials
Other 16
NIH 3
U.S. Fed 3
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fuji
Cerilliant
Colorcon
Mallinckrodt
Fish and Richardson
QuintilesIMS
Baxter
Boehringer Ingelheim

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