This trial is evaluating whether ND0612 Solution for SC infusion will improve 2 primary outcomes and 2 secondary outcomes in patients with Parkinson Disease. Measurement will happen over the course of Baseline to the end of DBDD Maintenance Period (12 weeks).
This trial requires 381 total participants across 2 different treatment groups
This trial involves 2 different treatments. ND0612 Solution For SC Infusion is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"The main symptom of PD is rigidity. Other symptoms include bradykinesia, apathy, constipation, and postural instability. Other symptoms include weakness and tremors of the extremities and speech and swallowing problems." - Anonymous Online Contributor
"The most common drugs used to treat Parkinson's disease at our center are those used for other diseases. This trial also confirmed that [L-DOPA can reduce hallucinations, tremors, and dystonia by inhibiting the peripheral breakdown of L-DOPA in most patients.] Patients with Parkinson's disease can take L-DOPA. Although L-DOPA can inhibit peripheral benzodiazepine-like receptor (BZD1) receptors, a [BZD1 receptor agonist], such as rotigotine, can increase their ability to alleviate the symptoms of Parkinson's disease. Moreover, we need a better understanding how dopamine and levodopa interact and work together." - Anonymous Online Contributor
"Currently, no causal factor can explain why individuals with Parkinson disease develop the disease. The cause is likely multifactorial in a similar way to Alzheimer's disease. There are several theories. One of them assumes a chronic, subclinical oxidative stress to be a cause. It may occur over time, or may be a risk factor. Another theory is that it results from an accumulation of genetic damage due to factors including free radicals, oxidative stress, and viral infections in the early stages of life. Some research has also found a link between an individual's dopamine transporter gene type and the development of Parkinson's disease. Genetic factors, lifestyle, genetics, and environmental factors appear to be of utmost concern in the causation and onset of Parkinson's disease." - Anonymous Online Contributor
"There are at least four distinct forms of PD: parkinsonism alone (sometimes followed by tremor); parkinsonism plus resting tremor; parkinsonism alone in people age 65 and over; and parkinsonism with no tremor in younger people. The latter two forms are usually mild. In most people, PD is slowly progressive with symptoms becoming more severe. A diagnosis is made when symptoms are severe enough to limit activities and the diagnosis will often be made before the onset of symptoms." - Anonymous Online Contributor
"The estimated yearly prevalence of PD in the United States is 3.3/1,000 for whites, 3.7/1,000 for Hispanics, and 2.5/1,000 for blacks. Although PD is more common among African Americans (4.7/1,000) than people of other races (2-3/1,000), our estimation did not include persons of Hispanic or South Asian descent or those in the youngest age groups. In a recent study, findings should therefore be viewed as estimates. The prevalence estimates herein were derived from a meta-analysis of the two most recent large samples of U.S." - Anonymous Online Contributor
"Though many PD-affected individuals experience rapid and marked symptom improvement during the first 3 years of therapy, there is generally a substantial fall in their disability, and an eventual plateau of symptom severity at 3 years that persists throughout the remainder of their lives. Thus, PD can be defined as a chronic, incurable disorder that must always be under therapy, though not necessarily with a cure in view." - Anonymous Online Contributor
"We have not demonstrated the clinical utility of sc infusion with ND-0612 compared to that of placebo for the treatment of PD. We were unable to show a clinically meaningful improvement in outcomes measured with the Scales-PD, MENTASA, or STAMPS-PD. The study was underpowered to detect a difference in disease severity between treatment groups with respect to any of the end points." - Anonymous Online Contributor
"Nd0612 Solution for sc Infusion is simple to administer with minimal side effects and can be considered as a treatment of choice for non-dopamine-responsive PD patients. Nd0612 solution for sc infusion provides a prolonged and robust symptomatic improvement, with a reduced rate of AEs, without compromising clinical efficacy." - Anonymous Online Contributor
"Nd0612 was found to be better than a placebo, and was well tolerated in pediatric patients with advanced PD, with a significant improvement of two main parameters: motor function, and Parkinson's Disease Impact Scale (PDIS) ratings." - Anonymous Online Contributor
"Sc infusions were relatively safe and well tolerated. The most common side effects were transient nausea and vomiting. Patients in the PDRT-C-3 group had less nausea and improved overall QoL compared with patients in the C-1 and C-2 groups in the first 4 weeks of treatment." - Anonymous Online Contributor
"The effectiveness of nd0612 at the dose of 200 to 400 U/h per day can be enhanced by combining it with other drugs such as the L-DOPA preparations, anticholinergics, and dopa decarboxylase inhibitors, all of them currently being used in combination for treating PD patients." - Anonymous Online Contributor