Idebenone Treatment of Early Parkinson's Diseasesymptoms

• Status: Unknown status
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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。

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Soochow University
• Collaborator: Qilu Pharmaceutical Co., Ltd.
• Treatments: Idebenone; Ubiquinone

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.