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Seizure Therapy With Intravenous Levetiracetam and Lorazepam

NCT00465244 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2012-11-01

No results posted yet for this study

Summary

The overarching aim of STILL is assessment of IV LEV in the management of seizures in the ED setting. The main study endpoints are considered in the two patient groups of interest (SE and non-SE):

* For non-SE patients, STILL will compare IV LEV vs. the current standard-care of placebo, with respect to the following questions:
* Does IV LEV administration result in lower seizure duration and/or recurrence rate than does administration of placebo? (Ho: No difference in seizure duration or recurrence rates between the two groups.)
* Is IV LEV associated with a different rate of significant side effects than placebo? (Ho: No difference in significant side effect rates between the two groups.)
* For SE patients, STILL will compare \[IV LEV + lorazepam 2mg\] vs. \[lorazepam 3 mg\], with respect to the following questions:
* Does addition of IV LEV to a BZD allow for a BZD-sparing effect (i.e. achievement of seizure control with lower dose of BZD)? (Ho: No difference in seizure duration and/or recurrence rates between the two groups.)
* Is IV LEV + lower-dose BZD associated with a different rate of significant side effects than the higher-dose BZD administered as monotherapy? (Ho: No difference in significant side effect rates between the two groups.)

Conditions

Interventions

DRUG

Levetiracetam 1 g IV + Lorazepam 2 mg IV

Levetiracetam 1 g IV + Lorazepam 2 mg IV

DRUG

Placebo + Lorazepam 3 mg IV

Placebo + Lorazepam 3 mg IV

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Joshua N. Goldstein, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00465244 on ClinicalTrials.gov