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| ID | Type | Description | Link |
|---|---|---|---|
| OCR14673 | Other Identifier | University of Florida |
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The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.
Because seizures are one of the leading neurologic complications in brain tumor patients, neurosurgeons prescribe antiepileptic drugs (AEDs) to help prevent them. Although the American Academy of Neurology (AAN) guidelines recommend that AEDs be stopped after the first post-operative week in patients without seizures, there is no standard length of treatment and some patients may stay on AEDs indefinitely.
In an attempt to develop clinical guidelines for AED use in post-operative brain tumor patients, we will try to determine if taking levetiracetam for 1 week results in less neurotoxicity than taking it for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Week Levetiracetam | Experimental | Levetiracetam taken by mouth at a daily dose of 1000 mg for one week. |
|
| 6 Week Levetiracetam | Active Comparator | Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurotoxicity Scale Scores | The Neurotoxicity Scale is as a validated 27 question, patient-reported measure for assessing the adverse effects of antiepileptic drugs on cognitive function. Patients self-report "no problem", "a mild problem", "a moderate problem" or "a serious problem" for each question corresponding to a score of 0, 1, 2, and 3, respectively. For each patient, the overall score was formed by summing scores in all 27 questions. The minimum possible score is 0 and the maximum possible total score is 81. A lower score indicates less toxicity when taking an antiepileptic drug. The outcome is a score change from baseline at the 6 week follow-up and is calculated by subtracting the baseline score from the 6 week follow-up score for each patient. | Baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Rahman, MS, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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The first subject was enrolled in this trial on 8/5/2015 and the last on 8/27/2020 at an academic medical center in a Neurosurgical inpatient/outpatient setting. Potential participants were adult (>18 years of age and older) patients, with no seizure history, who had or will have had undergone surgical resection of a supratentorial brain tumor and were able to consent for themselves.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for one week. Levetiracetam |
| FG001 | 6 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks. Levetiracetam |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects were screened against eligibility criteria. Subjects with a history of seizures, depression or use of psychiatric medications, Beck-Depression Inventory score over 14, biopsy only or other factors were determined ineligible. Potential participants who may have been eligible also declined participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for one week. Levetiracetam |
| BG001 | 6 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks. Levetiracetam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age of participants in each arm |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Neurotoxicity Scale Scores | The Neurotoxicity Scale is as a validated 27 question, patient-reported measure for assessing the adverse effects of antiepileptic drugs on cognitive function. Patients self-report "no problem", "a mild problem", "a moderate problem" or "a serious problem" for each question corresponding to a score of 0, 1, 2, and 3, respectively. For each patient, the overall score was formed by summing scores in all 27 questions. The minimum possible score is 0 and the maximum possible total score is 81. A lower score indicates less toxicity when taking an antiepileptic drug. The outcome is a score change from baseline at the 6 week follow-up and is calculated by subtracting the baseline score from the 6 week follow-up score for each patient. | All patients taking levetiracetam 1000 mg daily, not stratified by dosing schedule. | Posted | Median | Full Range | score on scale | Baseline to 6 weeks |
|
Adverse events will be collected from first dose of study drug to six week evaluation or sooner if the patient contacts their physician/study team about new symptoms/problems.
Participants at risk for all-cause mortality included any participant who signed consent to take part in the study. Participants at risk for Serious Adverse Events and Other (not including serious) Adverse Events included only participants who received study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for one week. Levetiracetam |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphasia | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristine Wynne | University of Florida | 352-273-9727 | kristine.wynne@neurosurgery.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2019 | Oct 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Unable to obtain medication |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Percent of subjects that are male or female. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Percentage of participants identifying as a particular ethnicity in each arm | Count of Participants | Participants |
|
| Race (NIH/OMB) | Percentage of participants identifying as a particular race in each arm | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Levetiracetam taken by mouth at a daily dose of 1000 mg for one week. Levetiracetam |
| OG001 | 6 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks. Levetiracetam |
|
|
|
| 2 |
| 40 |
| 11 |
| 39 |
| 27 |
| 39 |
| EG001 | 6 Week Levetiracetam | Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks. Levetiracetam | 0 | 41 | 7 | 37 | 22 | 37 |
| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Cerebral edema | Nervous system disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Meningitis | Infections and infestations | Systematic Assessment |
|
| Weakness | Nervous system disorders | Systematic Assessment |
|
| Pseudomeningocele | Nervous system disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Spinal Hematoma | Vascular disorders | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | Non-systematic Assessment |
|
| Hip Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Mental Status Change | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | Non-systematic Assessment |
|
| Facial Swelling | Gastrointestinal disorders | Non-systematic Assessment |
|
| Incision Pain | General disorders | Non-systematic Assessment |
|
| Mental Status Change | Psychiatric disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Vision Change | Eye disorders | Non-systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |