ITEP: Idebenone Treatment of Early Parkinson's Diseasesymptoms
Study Details
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 |
|---|---|---|
|
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
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
- Evaluation of the efficacy on motor symptoms and non-motor symptoms [48weeks]
UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD)
Eligibility Criteria
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);
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(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:
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(1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points)
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(2)Patients with Parkinson's superimposition syndrome and patients with secondary Parkinson's syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.)
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(3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.);
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(4)Patients who have taken coenzyme Q10 or idebenone within three months;
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(5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment;
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(6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal);
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(7)Patients who cannot cooperate with the neuropsychological test;
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(8) Patients with poor compliance, not following the prescribed treatment regimen.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Second Affiliated Hospital of Soochow University
- Qilu Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SZDX-1