UC Davis Health Clinical Studies

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

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

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

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 Safety and Effectiveness of Experimental ADS-5102 For Multiple Sclerosis With Walking Impairment

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This study will test the effectiveness, safety, and tolerability of the experimental drug ADS-5102. It will be tested in people with difficulty walking caused by multiple sclerosis (MS). "Experimental" means the study drug is not approved by the FDA for this condition. The active ingredient in ADS-5102 is called amantadine. Amantadine is FDA approved for other conditions. ADS-5102 is a formulation of amantadine that allows the drug to be taken up by the body slowly after it is swallowed. This kind of formulation is called an extended release (ER) formulation and allows the drug to be taken once a day.

Drug study, Phase 3
Any, age 18 to 70 years old

A Study of the Effectiveness and Safety of Oxiplex® Gel to Reduce Pain and Symptoms Following Lumbar Disc Surgery

Please consider joining this clinical research study if you are having surgery for a herniated lumbar disc.

This study will examine the safety and effectiveness of an experimental device called Oxiplex. Oxiplex gel is not yet approved in the U.S. by the FDA. Oxiplex may help prevent some of the side effects that can occur after lower back spine surgery. This includes leg pain not resolved with surgery, back pain, and neurological symptoms such as weakness and numbness. Oxiplex gel is a sterile, bioresorbable (dissolves and absorbs into the body) product. The gel does not require removal after surgery and clears from the body. Oxiplex may improve post-surgical leg and back pain by providing a physical barrier for the nerves around your surgical site. It is applied during the lumbar spine surgery to coat the sensory nerves. This barrier isolates the nerves from tissues and fluid that may cause inflammation in that area.

Device study
Any, age 22 to 70 years old

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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