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The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization.
Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.
Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iv SPM 927 and oral placebo tablet | Drug | 60-minute infusion iv SPM 927 and oral placebo tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination | 2 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure counts | 2 days |
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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 |
|---|---|---|---|
| 17888078 | Result | Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19. |
| Label | URL |
|---|---|
| Clinical Study Summary on UCB.com | View source |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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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| oral SPM 927 tablet and iv placebo | Drug | 60-minute infusion placebo and oral SPM 927 tablet |
|
|
| iv SPM 927 and oral placebo tablet | Drug | 30-minute infusion iv SPM 927 and oral placebo tablet |
|
|
| oral SPM 927 tablet and iv placebo | Drug | 30-minute infusion placebo and oral SPM 927 tablet |
|
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |