Seizure Therapy With Intravenous Levetiracetam and Lorazepam - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	UCB, Inc.
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00465244

Purpose

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.)

Condition	Intervention	Phase
Seizures	Drug: Levetiracetam 1 g IV + Lorazepam 2 mg IV Drug: Placebo + Lorazepam 3 mg IV	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Seizure Therapy With Intravenous Levetiracetam and Lorazepam

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Levetiracetam Lorazepam

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Seizures [ Time Frame: hours ] [ Designated as safety issue: No ]
Mental status [ Time Frame: hours ] [ Designated as safety issue: No ]
Respiratory depression [ Time Frame: hours ] [ Designated as safety issue: Yes ]
seizure recurrence [ Time Frame: hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Levetiracetam 1 g IV + Lorazepam 2 mg IV	Drug: Levetiracetam 1 g IV + Lorazepam 2 mg IV Levetiracetam 1 g IV + Lorazepam 2 mg IV
2 Placebo + Lorazepam 3 mg IV	Drug: Placebo + Lorazepam 3 mg IV Placebo + Lorazepam 3 mg IV

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

seizure

Exclusion Criteria:

pregnancy
renal failure
hepatic impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465244

Contacts

Contact: Joshua N Goldstein, MD PhD

617 726 7622

jgoldstein@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

UCB, Inc.

Investigators

Principal Investigator:

Joshua N. Goldstein, MD, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Joshua N. Goldstein MD PhD )
Study ID Numbers:	STILL
Study First Received:	April 23, 2007
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00465244 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Prehospital and ED seizures

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Brain Diseases
Neuroprotective Agents
Lorazepam
Signs and Symptoms
Therapeutic Uses
Hypnotics and Sedatives
Nootropic Agents
Tranquilizing Agents
Nervous System Diseases

Seizures
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Diseases
Protective Agents
Pharmacologic Actions
Autonomic Agents
Epilepsy
Piracetam
Neurologic Manifestations
GABA Agents
Etiracetam
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on March 18, 2010