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Seizure Therapy With Intravenous Levetiracetam and Lorazepam (STILL)

This study has been withdrawn prior to enrollment.
(Inability to recruit subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465244
First Posted: April 24, 2007
Last Update Posted: November 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Joshua N. Goldstein, MD, PhD, Massachusetts General Hospital
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Seizure Therapy With Intravenous Levetiracetam and Lorazepam

Resource links provided by NLM:


Further study details as provided by Joshua N. Goldstein, MD, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Seizures [ Time Frame: hours ]
  • Mental status [ Time Frame: hours ]
  • Respiratory depression [ Time Frame: hours ]
  • seizure recurrence [ Time Frame: hours ]

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • seizure

Exclusion Criteria:

  • pregnancy
  • renal failure
  • hepatic impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465244


Sponsors and Collaborators
Massachusetts General Hospital
UCB Pharma
Investigators
Principal Investigator: Joshua N. Goldstein, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: Joshua N. Goldstein, MD, PhD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00465244     History of Changes
Other Study ID Numbers: STILL
First Submitted: April 23, 2007
First Posted: April 24, 2007
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Joshua N. Goldstein, MD, PhD, Massachusetts General Hospital:
Prehospital and ED seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Lorazepam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action