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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002843-18 | EudraCT Number |
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The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranirestat 80 mg | Experimental | Two 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. |
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| Ranirestat 40 mg | Experimental | One 40 mg tablet of Ranirestat and a matching placebo, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. |
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| Placebo | Placebo Comparator | Two placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranirestat | Drug | Ranirestat 40 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roderick Junor | Eisai Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26313450 | Derived | Polydefkis M, Arezzo J, Nash M, Bril V, Shaibani A, Gordon RJ, Bradshaw KL, Junor RW; Ranirestat Study Group. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. J Peripher Nerv Syst. 2015 Dec;20(4):363-71. doi: 10.1111/jns.12138. |
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| ID | Term |
|---|---|
| C115070 | ranirestat |
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| Placebo |
| Drug |
Placebo tablets |
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