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| Name | Class |
|---|---|
| Qilu Pharmaceutical Co., Ltd. | INDUSTRY |
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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。
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group 1 | Experimental | 60 cases, idebenone 180mg/d, 3 times / day, oral |
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| The control group 2 | Experimental | 60 cases, idebenone 360mg/d, 3 times / day, oral |
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| The placebo group | Placebo Comparator | 60 cases, placebo, 3 times / day, oral |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idebenone/placebo | Drug | The two control group will be given Idebenone in two different doses,and the placebo group will be given placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 48weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun Feng Liu, Professor | Contact | 13606210609 |
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| ID | Term |
|---|---|
| C036619 | idebenone |
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