Investigating efficacy and safety of adjunctive therapy in Parkinson’s Disease patients
Parkinson’s Disease involves the loss of brain cells that produce dopamine, a messenger that sends information to the parts of the brain that control movement and coordination. Lower than normal levels of dopamine in the brain causes the symptoms of Parkinson’s, including muscle stiffness, resting tremor (uncontrollable shaking), and slowing of movements. Parkinson’s patients may have “on” periods where they are able to control their muscle movement, and “off” times when controlling these movements is harder.
Levodopa is a medication used to help treat Parkinson’s by increasing dopamine levels in the brain. We are looking for participants who have these “on” and “off” periods, and who are on Levodopa and at least one other medication. We are looking at whether adding tozadenant, a drug that hasn’t been approved by the U.S. FDA, will help improve Parkinson’s symptoms.
Recruiting | parkinsons adjunctive therapy | Not Multisite
Assessing the safety and efficacy of Macitentan in patients with portopulmonary hypertension
Several drugs (blood vessel dilators), including macitentan, are currently approved for the treatment of pulmonary arterial hypertension (PAH) in many parts of the world. These drugs have significantly improved the outcome of the condition. However, none of these treatments have been evaluated in portopulmonary hypertension, a form of PAH caused by liver disease. The purpose of this study is to assess the safety and effectiveness of macitentan in portopulmonary hypertension by looking at several clinical indicators, including the pressures within the arteries of the lungs and a person’s capacity for exercise.
Recruiting | High Blood Pressure / Hypertension | Not Multisite
VX-770 Expanded Access Program (EAP)
VX-770, a compound being developed by Vertex Pharmaceuticals Incorporated (Vertex) for the
treatment of CF, is an orally bioavailable small molecule that targets the underlying defect
in CF, the dysfunctional CFTR protein. In Phase 3 studies of VX-770 in patients with CF and
a G551D CFTR mutation, improvements in CFTR function (measured by reduction in sweat
chloride concentration) and improvements in lung function were observed.
Patients who are interested in the VX-770 Expanded Access should contact their CF physician
about participation.
Physicians interested in participating as a site should contact 800-745-4484.
Approved for marketing | Cystic Fibrosis | Site Unknown
How does a stroke affect balance during walking?
<p>The purpose of this study is to understand how a stroke affects walking balance and why people post-stroke fall more frequently. Findings from this study could inform the design of rehabilitation interventions to improve post-stroke walking ability.</p><p><strong>We are looking for</strong> <strong>people who have had a stroke AND healthy adults who have not had a stroke. </strong>Participants will walk on a treadmill while experiencing trips that challenge balance, but a safety harness will be worn to prevent any falls.</p>
USC GeneScreen: The USC Alzheimer’s Prevention Registry
<p>Researchers at USC invite you, and your friends and family, to <u>enroll online</u> in USC GeneScreen, USC Alzheimer's Prevention Registry.</p><p>Alzheimer’s disease is a brain disease that affects memory, thinking, and behavior. It is a progressive brain disorder that causes severe memory loss over time, making it increasingly difficult for people to carry out daily activities. Alzheimer's disease impacts us all. </p><p> While valuable Alzheimer's research is being done every day to treat and prevent this disease, finding interested research participants remains an ongoing challenge. USC GeneScreen is a registry for people who are interested in participating in Alzheimer’s disease research studies at USC. By joining the registry, members are the first to hear about new and innovative studies that they may be eligible to participate in. </p>
A Phase III, Open-Label, Extension Trial of ECU-MG-301 to
Evaluate the Safety and Efficacy of Eculizumab in Subjects with Refractory Generalized
Myasthenia Gravis (gMG).
This is a phase III, open label, extension trial of ECU-MG-301(HS-13-00805) to evaluate the safety and efficacy of Eculizumab in subjects with refractory generalized myasthenia gravis (gMG). Eculizumab is a humanized monoclonal antibody that was derived from the murine anti-human C5 antibody m5G1.1. Myasthenia Gravis is a rare, debilitating, acquired autoimmune disease of the neuromuscular junction (NMJ), clinically characterized by weakness and fatigability of skeletal muscle. Since complement activation plays a pivotal role in the pathophysiology of MG, eculizumab, a terminal complement inhibitor, as such may benefit patients who continue to have generalized weakness and bulbar signs and symptoms despite current standard of care.
The primary objective of this trial is to evaluate the long-term safety of eculizumab in subjects with refractory gMG. Subjects who complete the 26-week treatment period (Visit 17) in the ECU-MG-301(HS-13-00805) trial may potentially enter this extension trial. There will be 3 periods in this study, Blind Induction Phase, Open-Label Maintenance Phase and Safety Follow-up Period. To preserve the blinded nature of the ECU-MG-301 trial, all subjects must undergo a blind induction phase and will receive blinded Investigational Product (IP) weekly for four (4) doses. Patients who were randomized to the placebo arm in the ECU-MG-301 trial will receive 4 vials IP (3 vials/900 mg eculizumab plus 1 vial placebo) at Visits 1 to 4. Patients who were randomized to the eculizumab arm in the ECU-MG-301 trial will continue to receive 4 vials IP (1200 mg eculizumab) every two weeks at Visits 1 and 3 and placebo at Visits 2 and 4. All subjects will receive open-label eculizumab (4 vials/1200 mg) every 2 weeks during the open level maintenance phase. On-Trial Rescue Therapy (high dose corticosteroid,plasmapheresis /plasma exchange (PE) or Intravenous Immunoglobulin,) will be allowed if a subject experiences clinical deterioration as defined in this protocol. For a subject who is discontinued from this trial, a follow-up visit for safety evaluation will be required. Primary efficacy endpoint is Safety and tolerability of eculizumab. Secondary Efficacy Endpoints will include the total change of QMG (Quantitative Myasthenia Gravis) score and total change of Myasthenia Gravis Composite (MGC) score. Safety analyses will be performed on the Safety Population and the Extension Safety Population includes all subjects who receive at least 1 dose of IP (eculizumab or Placebo). There is no interim analysis planned for this trial.
Enrolling by invitation | Myasthenia Gravis | Site Unknown
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of
osteorarthritis and degenerative disc disease. Anti-inflammatory components include
inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and
interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues,
including amniotic fluid, amniotic membrane and chorion are regulated as human cell and
tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft
materials for human injection. AlloGen-LI is derived from placental tissues obtained from
carefully screened healthy mothers at the time of scheduled cesarean section. The mothers
have agreed to donate the tissues, which would otherwise be discarded. The experimental
treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural
space under CT guidance, in an identical manner to traditional epidural steroid /marcaine
injections.
Enrolling by invitation | disc herniation | Not Multisite
Improving dermatologic care for psoriasis patients
We seek to evaluate an online psoriasis-care delivery model. Through this online model, patients can see the dermatologist online rather than coming into the office for a visit. The model is designed to increase patient and primary care physician access to dermatologists. We want to find out if this online model ultimately improves psoriasis severity and quality of life.
Tracking the Risk for Alzheimer’s Disease using the APT Webstudy
The Alzheimer Prevention Trials (APT) Webstudy is designed to accelerate enrollment into Alzheimer’s clinical trials by identifying and tracking individuals online, who may be at higher risk for developing Alzheimer’s. The Alzheimer’s Association estimates that 5.5 million Americans age 65 and older are currently living with Alzheimer’s dementia. It’s believed these numbers will increase by almost 30% to over 7 million people by 2025, where it’s the only top 10 cause of death that cannot be prevented, cured, or even slowed. The APT Webstudy is open to anyone over the age of 50. The goal of the APT Webstudy is to develop an online group of individuals who will allow their memory and thinking test scores to be tracked over time. Participants will have the opportunity to take online tests to assess their memory and thinking skills, gain access to their scores, and be notified of opportunities for in-person assessments and clinical trials aimed at preventing dementia. These in-person visits will be offered through the closest clinical site to participants.
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