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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

About this trial

This is an interventional treatment trial for Oxidative Stress is an Important Cause of Parkinson's Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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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