Seizure Therapy With Intravenous Levetiracetam and Lorazepam (STILL)

This study has been withdrawn prior to enrollment.
(Inability to recruit subjects)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Joshua N. Goldstein, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00465244
First received: April 23, 2007
Last updated: October 30, 2012
Last verified: October 2012
  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
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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Joshua N. Goldstein, MD, PhD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00465244     History of Changes
Other Study ID Numbers: STILL
Study First Received: April 23, 2007
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Nootropic Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 11, 2014