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Idebenone Treatment of Early Parkinson's Diseasesymptoms (ITEP)

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ClinicalTrials.gov Identifier: NCT03727295
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Qilu Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Second Affiliated Hospital of Soochow University

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.


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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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727295


Contacts
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Contact: Chun Feng Liu, Professor 13606210609

Sponsors and Collaborators
Second Affiliated Hospital of Soochow University
Qilu Pharmaceutical Co., Ltd.

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Responsible Party: Second Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03727295     History of Changes
Other Study ID Numbers: SZDX-1
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ubiquinone
Idebenone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances