search
Back to results

Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study

Primary Purpose

Seizure, Alcohol Related

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levetiracetam
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizure, Alcohol Related focused on measuring Alcohol seizure

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • No trauma
  • Not pregnant
  • No other cause for seizure (hypoglycemia, CNS causes, trauma)
  • Good family support
  • Working telephone contact

Exclusion Criteria:

  • Pregnancy
  • Renal failure (creatine > 2mg/dl
  • Fever or illness
  • Hypotension
  • Any trauma

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Decreased seizures

Secondary Outcome Measures

Full Information

First Posted
February 20, 2008
Last Updated
June 5, 2018
Sponsor
Medical University of South Carolina
Collaborators
UCB Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT00627133
Brief Title
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study
Official Title
A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Withdrawn
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizure, Alcohol Related
Keywords
Alcohol seizure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Intervention Description
2 gram iv load, 500mg bid
Primary Outcome Measure Information:
Title
Decreased seizures
Time Frame
1, 2, 4, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: No trauma Not pregnant No other cause for seizure (hypoglycemia, CNS causes, trauma) Good family support Working telephone contact Exclusion Criteria: Pregnancy Renal failure (creatine > 2mg/dl Fever or illness Hypotension Any trauma
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study

We'll reach out to this number within 24 hrs