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The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPM927/Lacosamide | Drug | SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy | Assessments throughout the trial, either daily and/or at clinic visits |
| Measure | Description | Time Frame |
|---|---|---|
| Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation) | Daily assessment during entire trial participation including visits at the site | |
| Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17237664 | Result | Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2. |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| C476828 | 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- |
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Other | Placebo tablets two times a day for 10 weeks |
|
|
| Daily assessment during entire trial participation including visits at the site |
| Investigate the tolerability and safety of SPM927 (assessment during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
| Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |