Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04957420 |
| Other study ID # |
D2021060 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
Peking University Third Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a multicenter, prospective, non intervention post marketing surveillance study
conducted in Chinese mainland. The main objective was to evaluate the safety characteristics
of rotigotine patch in the treatment of Chinese adult patients with idiopathic Parkinson's
disease in real world clinical practice.
Description:
Parkinson's disease (PD) is a long-term, chronic, progressive and disabling disease, which
affects millions of patients worldwide. The incidence rate of Parkinson's disease is about
20/100000 per year. With the increase of age (65 years old and above), the incidence rate of
the population increased significantly, reaching >100/100000 per year . The average age of
onset is 58 to 62 years old, and the prevalence rate of people over 50 years old is about 1%.
Similar to the incidence rate, the prevalence of Parkinson's disease increases with age. It
is 1.4% at 55 years old, and 4.3% in 85 years old and above.
The main clinical symptoms of Parkinson's disease include tremor, myotonia, motor
retardation, postural reflex disorders and gait disorders, as well as a variety of other
motor, mental, sensory and autonomic neuropathy. Depressive symptoms of Parkinson's disease
are very common in patients. In the progressive stage of the disease, patients may have
dementia symptoms. Autonomic nervous system involvement may cause orthostatic hypotension,
paroxysmal flushing, thermoregulation disorders, constipation, dysphagia, bladder and sexual
dysfunction. Involvement of dopaminergic pathways in the thalamus and spinal cord may lead to
sensory abnormalities.
The etiology of Parkinson's disease remains unclear. However, it is generally considered to
be a progressive degenerative disease, which gradually erodes the brain stem, basal ganglia
structure and its projection system. Pathological studies have found that there are loss of
dopaminergic neurons in substantia nigra and neurons in locus coeruleus and raphe nucleus,
deposition of Lewy bodies and activation of glial cells. Basic studies suggest that oxidative
damage of specific neurons in basal ganglia is one of the potential causes of idiopathic
Parkinson's disease, and aging and genetic factors are also the main causes of the disease
Predisposing factors.
Rotigotine ((6S) - 6 - {propyl [2 - (2-thienyl) ethyl] amino} -
5,6,7,8-tetrahydro-1-naphthol) is the left-handed enantiomer of chiral
aminotetrahydronaphthalene compounds. Rotigotine is a dopamine receptor agonist. Its dosage
form is designed as a transdermal drug delivery system, which can continuously release
rotigotine within 24 hours. Transdermal drug delivery system, which continuously releases
dopamine receptor agonists (such as rotigotine) in a non-invasive manner. Rotigotine has been
approved by global health agencies for the treatment of early and advanced Parkinson's
disease. Overall, ushib or authorized partners have market licenses for rotigotine
transdermal patches for Parkinson's disease in 70 countries. A detailed description of the
preclinical and clinical experience of rotigotine can be found in the investigator's manual.
From February 15, 2006 to February 15, 2020, a total of 7878 participants used rotigotine as
part of the clinical development plan. No treatment-related risk was found in the longest
6-year long-term open study. Other safety features of rotigotine, including clinical and post
marketing data, can be found in the investigator's manual.
According to the current policy of the Chinese government, multinational pharmaceutical
companies operating in China should implement drug safety monitoring within five years after
obtaining the registration certificate of imported drugs. This kind of research is called
focused drug monitoring (IDM), which aims to investigate the safety and clinical application
of products, including expected and unexpected adverse drug reactions (ADRs); Specific
adverse reactions / events are related, incidence rate, severity, risk and so on. The
incidence of ADR in special groups, including pregnant women, children, the elderly, patients
with liver and kidney damage, specific race, patients with specific genetic tendency or
specific complications, and other people who lack safety data of pre marketing clinical
studies; Other safety problems related to drug use, packaging and quality were observed.
During IDM, general population monitoring should be used unless there are other requirements
for special reasons (such as requirements or permission of drug regulatory agencies).
Observational studies are recommended. According to the data collection method, prospective
study is recommended. However, in order to collect data as comprehensively as possible,
prospective and retrospective studies can also be combined. Literature research can be used
as a brief supplement to key monitoring methods. In order to avoid information collection
bias during IDM, case selection should be continuous, such as collecting information of all
patients using drugs in a specific time period and fixed medical institutions; Other biases
should also be considered in planning. According to the requirements of China's State Food
and Drug Administration (CFDA) / State Drug Administration (nmpa), Neupro®（ The safety
characteristics of rotigotine patches need to be evaluated using a sample of at least 3000
patients.
The purpose of this non intervention study (NIS) was to evaluate the safety of rotigotine
patch in adult patients with idiopathic Parkinson's disease according to the instructions in
routine clinical practice, so as to meet the regulatory requirements of Chinese health
institutions. This study will collect and monitor all adverse events (AE). Evidence of the
efficacy and use of rotigotine patches in the real world will also be collected with AE.
