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| Name | Class |
|---|---|
| McMaster University | OTHER |
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This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seizure Prophylaxis (Levetiracetam) | Experimental | Levetiracetam 1 g taken orally twice a day for 7 days |
|
| Placebo | Placebo Comparator | Placebo taken orally twice a day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Feasibility outcome | Through study completion, approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of eligible patients approached | Through study completion, approximately 1 year | |
| Fraction of approached patients consent | Through study completion, approximately 1 year | |
| Measure | Description | Time Frame |
|---|---|---|
| New onset seizure within 7 days of surgery | 7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14 | |
| Incidence of infection during Study Drug administration | Follow-up between post-operative day 8 and 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taylor Duda, MD | Contact | 905-521-2100 | 44155 | taylor.duda@medportal.ca |
| Amanda Martyniuk, MSc | Contact | 905-521-2100 | 44155 | martynia@mcmaster.ca |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Other |
Tablets |
|
| Role of individual who approached patients |
Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.) |
| Through study completion, approximately 1 year |
| Protocol adherence | Number of participants who withdrawal from the study | Through study completion, approximately 1 year |
| Protocol adherence | Drug adherence rate | Through study completion, approximately 1 year |
| Protocol adherence | Follow-up completion rate | Through study completion, approximately 1 year |
| Protocol adherence | Method of follow-up (e.g. telephone, clinic visit) | Through study completion, approximately 1 year |
| Adverse events | Serious and related adverse events and adverse drug reactions | Through study completion, approximately 1 year |
| Unblinding events | Number of events and reasoning | Through study completion, approximately 1 year |
| Incidence of psychiatric symptoms during Study Drug Administration | Follow-up between post-operative day 8 and 14 |
| Length of hospital stay in days | Hospital discharge |
| Incidence of administration of any antiepileptic drugs | Follow-up between post-operative day 8 and 14 |
| Incidence of administration of any benzodiazepines | Follow-up between post-operative day 8 and 14 |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |