Idebenone Treatment of Early Parkinson's Diseasesymptoms (ITEP)
Primary Purpose
Oxidative Stress is an Important Cause of Parkinson's Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Idebenone/placebo
Sponsored by
About this trial
This is an interventional treatment trial for Oxidative Stress is an Important Cause of Parkinson's Disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
The control group 1
The control group 2
The placebo group
Arm Description
60 cases, idebenone 180mg/d, 3 times / day, oral
60 cases, idebenone 360mg/d, 3 times / day, oral
60 cases, placebo, 3 times / day, oral
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03727295
First Posted
October 30, 2018
Last Updated
October 30, 2018
Sponsor
Second Affiliated Hospital of Soochow University
Collaborators
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03727295
Brief Title
Idebenone Treatment of Early Parkinson's Diseasesymptoms
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Soochow University
Collaborators
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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。
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress is an Important Cause of Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The control group 1
Arm Type
Experimental
Arm Description
60 cases, idebenone 180mg/d, 3 times / day, oral
Arm Title
The control group 2
Arm Type
Experimental
Arm Description
60 cases, idebenone 360mg/d, 3 times / day, oral
Arm Title
The placebo group
Arm Type
Placebo Comparator
Arm Description
60 cases, placebo, 3 times / day, oral
Intervention Type
Drug
Intervention Name(s)
Idebenone/placebo
Intervention Description
The two control group will be given Idebenone in two different doses,and the placebo group will be given placebo
Primary Outcome Measure Information:
Title
Evaluation of the efficacy on motor symptoms and non-motor symptoms
Description
UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD)
Time Frame
48weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Feng Liu, Professor
Phone
13606210609
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Idebenone Treatment of Early Parkinson's Diseasesymptoms
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