Idebenone Treatment of Early Parkinson's Diseasesymptoms (ITEP)

• ClinicalTrials.gov Identifier: NCT03727295
• Recruitment Status: Unknown
• First Posted: November 1, 2018
• Last Update Posted: November 1, 2018
• Sponsor: Second Affiliated Hospital of Soochow University
• Collaborator: Qilu Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Second Affiliated Hospital of Soochow University

Study Description

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。

Condition or disease	Intervention/treatment	Phase
Oxidative Stress is an Important Cause of Parkinson's Disease	Drug: Idebenone/placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: January 1, 2019
• Estimated Primary Completion Date: December 30, 2020
• Estimated Study Completion Date: May 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Evaluation of the efficacy on motor symptoms and non-motor symptoms [ Time Frame: 48weeks ]
   UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD)

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Chun Feng Liu, Professor; 13606210609

Sponsors and Collaborators

Second Affiliated Hospital of Soochow University

Qilu Pharmaceutical Co., Ltd.

More Information

• Responsible Party: Second Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT03727295
• Other Study ID Numbers: SZDX-1
• First Posted: November 1, 2018
• Last Update Posted: November 1, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Idebenone; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs