UC Davis Health Clinical Studies

A Study to Test the Effectiveness and Safety of Experimental Padsevonil for Seizures in Adults With Drug-Resistant Epilepsy

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Seizures are caused by abnormal electrical disturbances in the brain. Focal-onset seizures occur when this electrical activity remains in a limited area of the brain. Seizures can sometimes turn into generalized seizures (also called Grand Mal seizures), which affect the whole brain. The purpose of this study is to test the effectiveness, safety, and tolerability of a new experimental drug called padsevonil. The study drug will be given in one of 3 different doses along with your current epilepsy treatment that may consist of 1-3 antiepileptic drugs. The study also aims to see how safe padsevonil is compared to placebo and how well your body can tolerate it. This study involves the use of both padsevonil and placebo tablets that look exactly the same. The placebo does not contain any active ingredients. Placebo as well might have effect on your seizures and wellbeing. You have an equal chance (like rolling a dice) of being assigned to one of the 4 treatment groups: - padsevonil 200 mg/day, - padsevonil 400 mg/day, - padsevonil 800 mg/day or - placebo. Padsevonil is a medicine particularly made to better control seizures in people who are resistant to other anti-seizure drugs. It has not yet been approved by drug authorities such as FDA, for the treatment of any disease, including focal-onset seizures.

Drug study, Phase 3
Any, age 18 years or older

Experimental Iobenguane I-131 or Crizotinib and Standard Therapy For Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma

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In this study, researchers want to find out if we can improve the treatment for subjects with high risk Neuroblastoma (NBL). We will study the addition of experimental drug I-MIBG or the experimental drug Crizotinib to standard therapy. We also want to find out if we can reduce the number of stem cell transplants from two to one. I-MIBG is an experimental anticancer drug. It has not been approved by the FDA for use in treating high-risk NBL. I-MIBG has been used to treat NBL that did not respond to therapy or NBL that has come back. I-MIBG has been shown to be well tolerated in children with cancer. I-MIBG can only be given at certain hospitals and you may need to travel to another hospital if you choose to participate in this study. Some patients in the study will receive only one stem cell transplant instead of two back-to-back stem cell transplants. Subjects who have only one stem cell transplant will get two chemotherapy drugs called busulfan and melphalan (BuMel). These are given instead of the drugs usually used for back-to-back stem cell transplants. BuMel is an accepted transplant chemotherapy regimen in Europe and other parts of the world. It is not part of current Children's Oncology Group (COG) recommended therapy. Crizotinib is an experimental anticancer drug. It has not been approved by the FDA for use in treating high-risk NBL. Crizotinib has been approved by the FDA for use in treating adults with certain types of lung cancer that has spread. Crizotinib has been well-tolerated in children and adults with cancer. Crizotinib will only be used in subjects whose tumor shows changes in a gene called ALK. Changes in the ALK gene are only found in 10-15% of children with high-risk NBL. The overall goals of this study are to: • Compare the effects, good and/or bad, of the experimental drug I-MIBG added to current COG recommended therapy. • Compare the effects, good and/or bad, of the experimental drug crizotinib added to current COG recommended therapy. Another goal of this study is to: • Evaluate the effects, good and/or bad, of using the experimental drug I-MIBG in the setting of single cell transplant with BuMel conditioning during Consolidation therapy. These effects, good and/or bad, will be studied but will not be directly compared to current COG recommended therapy.

Biological study, Phase 3
Any, age -1 to 30 years old

A Study to Test the Safety and Effectiveness of Experimental Elezanumab for Relapsing Forms of Multiple Sclerosis

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This study will test the investigational study drug, elezanumab. We hope to learn if it is safe and effective when added to the current treatment in adult subjects with relapsing forms of multiple sclerosis (RMS). Investigational means that the study drug has not been approved by the FDA. Elezanumab is being studied to determine if it will improve physical functioning in subjects with relapsing forms of MS who have disability.

Drug study, Phase 2
Any, age 18 to 65 years old

A Study of the Safety and Effectiveness of Experimental Elezanumab for Progressive Forms of Multiple Sclerosis

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The purpose of this study is to test the investigational study drug, elezanumab. We will test if elezanumab is safe and effective. It will be added to standard treatment in adults with progressive forms of multiple sclerosis (PMS). Investigational means that the study drug has not been approved for sale by the FDA. It is being studied to determine if it will improve physical functioning in patients with progressive forms of MS who have disability.

Drug study, Phase 2
Any, age 18 to 65 years old

A Study of the Long-Term Effects of Experimental ACE-083 for CMT type 1, CMT type X, or Facioscapulohumeral Muscular Dystrophy

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The purpose of this research is to test the long-term effects of the experimental medicine ACE-083. It will be studied in people who have Charcot-Marie-Tooth disease (CMT). CMT is a disorder that damages the nerves in the arms and legs. This study is for patients with CMT type 1, CMT type X, or Facioscapulohumeral Muscular Dystrophy (FSHD). Patients are invited to be in this study if they have previously received treatment with ACE-083 and have completed the A083-02 study. There are two parts to this research study, Part 1 and Part 2. Your participation in this research will involve either participation in Part 1 for 6 months or Part 2 for 24 months.

Drug study, Phase 2
Any, age 18 years or older

Clinical research study of a gene therapy for patients with Parkinson's Disease (RESTORE-1)

Please consider this clinical research study evaluating the safety and efficacy of an investigational gene therapy in Parkinson's Disease

This study will test the safety and efficacy of an investigational gene therapy in people with Parkinson's Disease. The purpose is to determine if the gene therapy is better than placebo at improving PD motor symptoms. The gene therapy introduces a gene with instructions for making an enzyme that plays an important role in the production of dopamine in the brain. The therapy is injected in the brain during a surgical procedure. This study is conducted at the UC Davis Department of Neurology. Surgery and some imaging will be performed at San Francisco VA. You will receive the investigational therapy and study evaluations at no cost. Additionally, transportation, hotel stay, and parking to and from visits is available free of charge. You will also receive additional compensation for your participation in study visits.

Phase 2 study, Gene therapy
Any, age 40 Years to 75 Years (inclusive)

A Study of the Safety and Effectiveness of Experimental RO7234292 for Huntington's Disease

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The purpose of this study is to compare the effects of experimetnal RO7234292 in study participants with Huntington’s Disease (HD). RO7234292 is an experimental drug, which means the FDA has not approved RO7234292 for the treatment of HD or any other condition. HD is a rare progressive neurological disease. It affects thought processes, movement, personality, and/or mood. Huntington’s Disease (HD) is caused by the production of a toxic protein within cells. RO7234292 (Study Drug) has been shown to lower levels of this protein in the first clinical trial by interfering with its production. It is hoped that reducing the production of this protein, progression of disease can be slowed or stopped. This study aims to test this idea.

Drug study, Phase 3
Any, age 25 to 65 years old

An Extension Study of Experimental AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed Study IN 11 004

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Parkinson's disease (or PD) is a disease that slowly damages the motor system. The motor system is the part of the central nervous system that is involved with movement. When a person gets Parkinson's disease, the cells that make dopamine in a part of the brain die. Dopamine cells send information to other cells which makes us do the actions we do. This study will test the long-term safety, tolerability and effectiveness of the experimental Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD). It will be used in patients with fluctuating Parkinson’s disease (PD) who completed the main study (IN 11 004). We will study how AP-CD/LD affects the symptoms of Parkinson’s disease long-term. We will evaluate participant responses on questionnaires, rating scales and examinations. Patients will also have the opportunity for extended treatment with AP-CD/LD. This will occur after they have successfully completed the main study IN 11 004. The name of the experimental drug that will take in this study is Accordion Pill™ Carbidopa/Levodopa. This is an oral drug (capsule) for the treatment of PD symptoms (motor and non-motor fluctuations). The Accordion Pill™ Carbidopa/Levodopa contains two drugs: levodopa combined with carbidopa. The Accordion Pill™ Carbidopa/Levodopa was developed by Intec Pharma Ltd. to extend the duration of the Levodopa activity and its effectiveness by keeping the drug in the stomach for a longer time. In this form, this product is known as the “experimental drug”. Experimental means that the drug has not yet been approved by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Drug study, Phase 3
Any, age 30 to 100 years old

A Study of Experimental Autologous Dendritic (immune) Cells With Autologous Tumor Antigens for Newly-Diagnosed Glioblastoma

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This study will test the safety and effectiveness of a patient-specific cellular immunotherapy. It will be given to patients who have newly-diagnosed glioblastoma cancer. The Sponsor of the study is AIVITA Biomedical, Inc. Our study team is helping to determine if an experimental immunotherapy (AV-GBM-1) will increase survival without harmful effects. AV-GBM-1 consists of a patient’s own dendritic cells (a type of immune cell). It is loaded with a patient’s own tumor-associated antigens (proteins that are made by their cancer cells) . The goal of this immunotherapy is to make a patient’s immune response better at fighting the existing tumor and to increase survival. GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. In this study, GM-CSF is given to enhance the immune effects of the treatment products. AV-GBM-1 is an experimental drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for standard use in the practice of medicine.

Biological study, Phase 2
Any, age 18 to 70 years old
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