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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

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 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

A Study of the Experimental Neuro-Spinal Scaffold™ Device for Complete Thoracic AIS A Spinal Cord Injury

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The purpose of this study is to test the safety and benefit of a new medical device. This device is implanted into the injured spinal cord for a recent spinal cord injury. The procedure to implant the medical device may be added to the usual, standard treatment for spinal cord injury. The study doctor will attempt to perform your surgery as soon as possible. The medical device is experimental and is not approved by the FDA. There is no evidence that the medical device will be of any benefit to you. However, the study will look at whether the new medical device helps improve the medical condition of patients with recent spinal cord injuries.

Device study
Any, age 16 to 70 years old

A Study of the Safety and Tolerability of Experimental WVE-120102 For Huntington's Disease

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Huntington's Disease (HD) is a rare progressive neurological disease. It affects thought processes, movement, personality, and/or mood. HD is caused by known mutations on a single gene, called the Huntingtin gene (HTT). This results in a repeat of 3 amino acids called the “CAG repeat”. All people carry the Huntingtin gene which makes Huntingtin protein. This protein is important for normal brain development. The CAG repeat on the HTT gene in people with HD leads to production of another type of protein known as the mutant Huntingtin (mHTT) protein. The study researchers believe if you can lower the amount of mHTT, you may be able to help treat Huntington’s Disease. Although treatments for symptoms are available, there is currently no cure for HD. The Sponsor is developing an experimental drug, WVE-120102. It has been developed to treat patients with HD with a mutation at a single point in their DNA, called a “SNP” (pronounced “snip”). SNP2 is often found on the HTT gene of HD patients and WVE-120102, the drug that will be investigated in this study, targets SNP2. Because the investigational drug being tested in this study is only expected to act on SNP2, we do not think the drug will help you if you do not carry SNP2. If you do not have SNP2 you will not be eligible for entry into this study. The purpose of this study is to determine if WVE-120102 is safe and well tolerated in the treatment of this disease when compared with a placebo control. WVE-120102 has not been tested previously in humans.

Drug study, Phase [/1/,/ /2/]
Any, age 25 to 65 years old

A Study of the Safety and Effectiveness of Experimental Perampanel For Partial Onset Seizures

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The purpose of the study is to investigate the study drug perampanel. The study team wants to learn if perampanel can be used alone without the need for combining with other antiepileptic medicines. It will also be studied as the first addition to existing medicine if only one seizure medication is being taken. Perampanel (E2007) is an experimental drug. This means that the drug being tested in this study and has not been approved by the FDA as an anti-epileptic medication.

Drug study, Phase 4
Any, age 12 years or older

A Study of the Experimental Medicine Olaparib For Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

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You are being asked to take part in this study because you have a tumor with an abnormal gene called IDH1 or IDH2. Your tumor may have grown or has recurred. There is no standard FDA approved treatment that is specific for people with this kind of abnormality in the tumor. People who are not in a study are usually treated with standard chemotherapy, immunotherapy, targeted therapies, surgery or radiation. These treatments may reduce your symptoms and slow down the growth of your tumor, but they are not curative. The purpose of this study is to test any good and bad effects of a drug called Olaparib. Researchers showed in the laboratory that Olaparib can shrink tumors like yours or stop its growth. Olaparib has already been FDAapproved to treat other cancers that have similar abnormalities. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size. Olaparib could shrink your cancer but it could also cause side effects. There will be about 145 people taking part in this study.

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