ND0612 Solution for SC infusion for Parkinson Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Axon Clinical s.r.o., Praha 5, Czechia
Parkinson Disease+1 More
ND0612 Solution for SC infusion - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations

See full description

Eligible Conditions

  • Parkinson Disease
  • Parkinson's Disease (PD)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

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).

Week 12
The change from Baseline to the end of the double-blind assessment period in OFF time per patient diary.
The change from Baseline to the end of the double-blind assessment period in daily ON time without troublesome dyskinesia (sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia) per patient diary.
Week 12
The change in daily OFF time
The change in daily ON time without troublesome dyskinesia

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Group B
1 of 2
Group A
1 of 2
Active Control
Experimental Treatment

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.

Group AND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
Group BPlacebo for ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to dbdd maintenance period (12 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to dbdd maintenance period (12 weeks) for reporting.

Closest Location

Oschner Medical Center - New Orleans, LA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/DDI, e.g.,Rytary®) at a total daily dose of ≥400mg.
Male and female patients, aged ≥30 years.
PD diagnosis consistent with the UK Brain Bank Criteria.
Modified Hoehn & Yahr score ≤3 during ON.
Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as confirmed by patient diary over 3 days.

Patient Q&A Section

What are the signs of parkinson disease?

"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

Unverified Answer

What are common treatments for parkinson disease?

"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

Unverified Answer

What causes parkinson disease?

"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

Unverified Answer

What is parkinson disease?

"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

Unverified Answer

How many people get parkinson disease a year in the United States?

"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

Unverified Answer

Can parkinson disease be cured?

"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

Unverified Answer

Does nd0612 solution for sc infusion improve quality of life for those with parkinson disease?

"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

Unverified Answer

What is nd0612 solution for sc infusion?

"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

Unverified Answer

Has nd0612 solution for sc infusion proven to be more effective than a placebo?

"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

Unverified Answer

What are the common side effects of nd0612 solution for sc infusion?

"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

Unverified Answer

Is nd0612 solution for sc infusion typically used in combination with any other treatments?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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