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Study Title Principal Investigator
A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose.
Recruiting | Parkinson's Disease | Multisite
Horacio Kaufmann
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
Mark Lew, MD
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Exercise targeting cognitive impairment in Parkinsons disease
Mild cognitive impairment (MCI), particularly of the executive function (EF) subtype, is common in Parkinson's disease (PD) and transitions to dementia, increased fall risk, and poor quality of life. There is currently no effective treatment of MCI in PD. Our animal and clinical studies in PD demonstrate that skilled exercise facilitates neuroplasticity of the basal ganglia (BG), a brain region sub-serving EF and supports the hypothesis that exercise will reverse EF deficits in PD. Furthermore, recent studies in healthy aging support that skill-based exercise that specifically promotes motor skill fitness (MSF), compared with aerobic exercise that promotes cardiovascular fitness (CF), has a greater impact on EF and related BG circuits. The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on MCI of the EF subtype in PD; we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates. Individuals with PD and MCI will be assigned to 1 of 3 groups (N = 50/group) involving 36 1-hr sessions over 12 weeks including either: (i) skill-based exercise; (ii) aerobic exercise or (iii) social-contact control. Specific Aim 1 tests the hypothesis that skill-based exercise will lead to greater improvement in EF as indexed by standardized neurocognitive measures of EF. We will also compare pre-post exercise related changes on CF and EF. Secondary outcome measures will compare pre-post exercise effects on self- efficacy, quality of life (PDQ39) and Parkinson disease severity (MDS-UPDRS). Specific Aim 2 will test the hypothesis that skill-based will lead to greater gains in EF, compared to aerobic exercise or a control group on the ability to generalize task performance as indexed by a validated context-dependent motor learning (CDML) task. Specific Aim 3 will test the hypothesis that skill-based exercise will lead to greater gains in EF compared to aerobic exercise or a control group by examining improved Dual Task motor performance and the corresponding more efficient neural activity of brain regions sub-serving EF. DT capability will be performed during an fMRI scale. All assessments, that include motor skill and cardiovascular fitness, will be made at baseline and at 12 weeks (post-intervention); a 3-month follow up for EF in SA1 will be done.
Recruiting | Parkinson's Disease | Not Multisite
Giselle M Petzinger, MD
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