Clinical trial NCT03727295: Idebenone Treatment of Early Parkinson's Diseasesymptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oxidative Stress is an Important Cause of Parkinson's Disease
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Qilu Pharmaceutical Co., Ltd.
First posted: 2018-11-01
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the efficacy on motor symptoms and non-motor symptoms
timeFrame: 48weeks
Secondary outcomes:
Other outcomes:
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