Idebenone Treatment of Early Parkinson's Diseasesymptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Oxidative Stress is an Important Cause of Parkinson's Disease

Intervention / Treatment
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* Drug: Idebenone/placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The control group 1<br>60 cases, idebenone 180mg/d, 3 times / day, oral | Drug: Idebenone/placebo<br>* The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo<br>|
| Experimental: The control group 2<br>60 cases, idebenone 360mg/d, 3 times / day, oral | Drug: Idebenone/placebo<br>* The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo<br>|
| Placebo Comparator: The placebo group<br>60 cases, placebo, 3 times / day, oral | Drug: Idebenone/placebo<br>* The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy on motor symptoms and non-motor symptoms | UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD) | 48weeks |