Idebenone Treatment of Early Parkinson's Diseasesymptoms (ITEP)

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

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。

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress is an Important Cause of Parkinson's Disease
• Intervention / Treatment: Drug: Idebenone/placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University
• Collaborators: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Idebenone
• Other Study ID Numbers: SZDX-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No