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Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.
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| Name | Class |
|---|---|
| UCB Pharma GmbH | INDUSTRY |
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The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.
The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg IV | Other | 100 mg IV lacosamide infused over 30 minutes |
|
| 200 mg IV | Other | 200 mg IV lacosamide infused over 30 minutes |
|
| 400 mg IV | Other | 400 mg IV lacosamide infused over 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of interictal spikes | One hour before and after drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency and quantity of background EEG rhythms | One hour before and after drug | |
| Change in EKG (QT, PR interval and heart rhythm) | One hour before and after drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to 4 hours after start of infusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard McLachlan, MD, FRCPC | London Health Sciences Centre, University Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada | ||
| London Health Sciences Centre |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| London |
| Ontario |
| N6A 5A5 |
| Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |