Trial · NCT00618436
Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
NCT00618436, Phase 4, Completed, University of Cincinnati; results first posted 2014-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention. Trials, record NCT00618436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00618436
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
- NCT number
- NCT00618436
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 52 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Interventions
- Levetiracetam, Phenytoin
- First posted
- 2008-02-20
- Last updated
- 2014-04-07
- Results first posted
- 2014-04-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Seizure Incidence | Duration of study, up to 6 months after the injury | This was the number of patients in each group who demonstrated seizure activity during the course of the study |
| Secondary | Extended Glasgow Outcome Score | at discharge; 3 and 6 months following injury | This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls. |
| Secondary | Disability Rating Scale (DRS) | Discharge; 3 and 6 months following injury | The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable. |
| Secondary | Incidence of Adverse Events | discharge; 3 and 6 months following injury |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Seizure Incidence | Duration of study, up to 6 months after the injury | Participants | NUMBER | |
| SECONDARY | Extended Glasgow Outcome Score | at discharge; 3 and 6 months following injury | All patients | units on a scale | MEAN |
| SECONDARY | Disability Rating Scale (DRS) | Discharge; 3 and 6 months following injury | All patients | units on a scale | MEAN |
| SECONDARY | Incidence of Adverse Events | discharge; 3 and 6 months following injury |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Seizure Incidence | Levetiracetam | 5 | Participants | ||
| Seizure Incidence | Phenytoin | 3 | Participants | ||
| Extended Glasgow Outcome Score | Levetiracetam | At Discharge | 2 | Full Range 1 to 4 | units on a scale |
| Extended Glasgow Outcome Score | Phenytoin | At Discharge | 2 | Full Range 1 to 3 | units on a scale |
| Extended Glasgow Outcome Score | Levetiracetam | At 3 months | 3 | Full Range 1 to 7 | units on a scale |
| Extended Glasgow Outcome Score | Phenytoin | At 3 months | 3 | Full Range 1 to 5 | units on a scale |
| Extended Glasgow Outcome Score | Levetiracetam | At 6 months | 3 | Full Range 1 to 8 | units on a scale |
| Extended Glasgow Outcome Score | Phenytoin | At 6 months | 3 | Full Range 1 to 7 | units on a scale |
| Disability Rating Scale (DRS) | Levetiracetam | At Discharge | 24 | Full Range 7 to 30 | units on a scale |
| Disability Rating Scale (DRS) | Phenytoin | At Discharge | 23 | Full Range 7 to 30 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levetiracetam | 34 | |
| Overall Study | STARTED | Phenytoin | 18 | |
| Overall Study | COMPLETED | Levetiracetam | 34 | |
| Overall Study | COMPLETED | Phenytoin | 18 | |
| Overall Study | NOT COMPLETED | Levetiracetam | 0 | |
| Overall Study | NOT COMPLETED | Phenytoin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam | ||
| Total, all-cause mortality | Phenytoin | ||
| Total, other adverse events | Levetiracetam | 0 | 34 |
| Total, other adverse events | Phenytoin | 0 | 18 |
| Total, serious adverse events | Levetiracetam | 0 | 34 |
| Total, serious adverse events | Phenytoin | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22342434 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Levetiracetam vs Phenytoin: Seizure Incidence | Trial comparisons |
| Levetiracetam vs Phenytoin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00618436
GET https://conductscience.org/api/trials/v1/NCT00618436/registered