Idebenone Treatment of Early Parkinson's Diseasesymptoms

Oxidative Stress is an Important Cause of Parkinson's Disease Clinical Trial

— ITEP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03727295
• Other study ID #: SZDX-1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2018
• Source: Second Affiliated Hospital of Soochow University
• Contact: Chun Feng Liu, Professor
• Phone: 13606210609
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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。

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Idebenone/placebo
The two control group will be given Idebenone in two different doses,and the placebo group will be given placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University	Qilu Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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