Oxidative Stress is an Important Cause of Parkinson's Disease
Conditions
Brief summary
On May 30,2018 ,Investigators intend to conduct a multicenter, randomized, double-blind, placebo-controlled study of idebenone in the treatment of early-stage Parkinson's disease with motor and non-motor symptoms which is to observe the therapeutic effect of idebenone on motor symptoms and non-motor symptoms in patients with early Parkinson's disease。
Detailed description
This clinical trail was a multicenter, parallel, randomized, double-blind, placebo-controlled study led by Professor Liu Chunfeng from the Second Affiliated Hospital of Suzhou University which consisted of 15 sub-centers with a total of 180 subjects. This clinical study is divided into two phases: The first stage: double-blind period, 24 weeks. Three queues containing idebenone 180 mg/d,360 mg/d and placebo. The second stage: open label extension period, 24 weeks. All enrolled participants continued to take idebenone 180 mg/d to study the long-term effects of idebenone.
Interventions
DRUGIdebenone/placebo
The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo
Sponsors
Qilu Pharmaceutical Co., Ltd.
Second Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (1) Male or female, age \> 30 years old, ≤ 80 years old; * (2) Conforms to the Diagnostic Criteria for Parkinson's Disease developed by the 2015 International Association of Sports Disabilities (MDS); * (3) Patients with early Parkinson's disease, duration \<3 years, Hoehn-Yahr classification:1-3, MMSE scale score ≥ 24 points; * (4)Receiving a stable dose of dopamine agonist or monoamine oxidase type B inhibitor for treatment before the enrollment; * (5) The subjects need to sign the Informed Consent Form（ICF）
Exclusion criteria
* (1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points) * (2)Patients with Parkinson's superimposition syndrome and patients with secondary Parkinson's syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.) * (3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.); * (4)Patients who have taken coenzyme Q10 or idebenone within three months; * (5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment; * (6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal); * (7)Patients who cannot cooperate with the neuropsychological test; * (8) Patients with poor compliance, not following the prescribed treatment regimen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy on motor symptoms and non-motor symptoms | 48weeks | UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD) |
Contacts
Primary ContactChun Feng Liu, Professor
Outcome results
None listed