Seizure Therapy With Intravenous Levetiracetam and Lorazepam

NCT00465244 | Withdrawn Phase 2 DMC

• 1 other identifier: STILL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Seizures

Keywords

Prehospital and ED seizures

Outcome Measures

Primary Outcomes (4)

• Seizures

  hours

• Mental status

  hours

• Respiratory depression

  hours

• seizure recurrence

  hours

Study Arms (2)

1

EXPERIMENTAL

Levetiracetam 1 g IV + Lorazepam 2 mg IV

Drug: Levetiracetam 1 g IV + Lorazepam 2 mg IV

2

OTHER

Placebo + Lorazepam 3 mg IV

Drug: Placebo + Lorazepam 3 mg IV

Interventions

Levetiracetam 1 g IV + Lorazepam 2 mg IV DRUG

Levetiracetam 1 g IV + Lorazepam 2 mg IV

1

Placebo + Lorazepam 3 mg IV DRUG

Placebo + Lorazepam 3 mg IV

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• seizure

You may not qualify if:

• pregnancy
• renal failure
• hepatic impairment

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• UCB Pharma: collaborator

MeSH Terms

Conditions

Seizures

Interventions

Levetiracetam; Lorazepam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joshua N. Goldstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 1, 2012

Record last verified: 2012-10