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

This study is not yet open for participant recruitment.

Verified by Medical University of South Carolina, February 2008

First Received: February 20, 2008 Last Updated: October 23, 2008 History of Changes

Sponsor:	Medical University of South Carolina
Collaborator:	UCB, Inc.
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00627133

Purpose

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

Condition	Intervention	Phase
Seizure, Alcohol Related	Drug: levetiracetam	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting

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: Ethanol Levetiracetam

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Decreased seizures [ Time Frame: 1, 2, 4, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: levetiracetam 2 gram iv load, 500mg bid

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627133

Contacts

Contact: Amy Robins, MD	843-792-9709	robins@musc.edu
Contact: Keith Borg, MD PhD	843-792-9709	borgk@musc.edu

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

UCB, Inc.

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Keith Borg MD PhD )
Study ID Numbers:	K17644
Study First Received:	February 20, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00627133 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Alcohol seizure

Additional relevant MeSH terms:

Alcohol-Induced Disorders
Nootropic Agents
Substance Withdrawal Syndrome
Neurotoxicity Syndromes
Seizures
Nervous System Diseases
Poisoning
Central Nervous System Diseases
Disorders of Environmental Origin
Alcohol Withdrawal Seizures
Brain Diseases

Pharmacologic Actions
Alcohol-Induced Disorders, Nervous System
Signs and Symptoms
Epilepsy
Therapeutic Uses
Substance-Related Disorders
Neurologic Manifestations
Etiracetam
Alcohol-Related Disorders
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010