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The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPM927/Lacosamide | Drug | SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits | |
| Adverse events reported spontaneously by the subject or observed by the investigator | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | |
| Changes laboratory, ECG and vital signs parameters. | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | |
| Changes in physical or neurological examination findings | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. | |
| Subject withdrawal due to adverse events | Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to gather further information on the efficacy of SPM 927 in this indication. | Daily assessment during entire trial participation including assessments at site visits | |
| Within-subject change in average pain score: Daily assessments throughout the trial |
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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 |
|---|---|---|---|
| 18619874 | Result | Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10. |
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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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| Daily assessment during entire trial participation including assessments at site visits |
| Change in subject's perception of different neuropathic pain qualities during specific site visit | Daily assessment during entire trial participation including assessments at site visits |
| Time to exit (days) de to lack of efficacy of treatment | Daily assessment during entire trial participation including assessments at site visits |
| Change in subject's perception of sleep and activity throughout the trial, daily assessments | Daily assessment during entire trial participation including assessments at site visits |
| Patient's Global Impression of Change in Pain (PGIC) during specific site visit | Daily assessment during entire trial participation including assessments at site visits |
| Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit | Daily assessment during entire trial participation including assessments at site visits |
| Quality of life assessments during specific site visits | Daily assessment during entire trial participation including assessments at site visits |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |