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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Medical University of South Carolina.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627133
First Posted: February 29, 2008
Last Update Posted: October 24, 2008
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:
Medical University of South Carolina
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Decreased seizures [ Time Frame: 1, 2, 4, 8 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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 Pharma
  More Information

Responsible Party: Keith Borg MD PhD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00627133     History of Changes
Other Study ID Numbers: K17644
First Submitted: February 20, 2008
First Posted: February 29, 2008
Last Update Posted: October 24, 2008
Last Verified: February 2008

Keywords provided by Medical University of South Carolina:
Alcohol seizure

Additional relevant MeSH terms:
Seizures
Alcohol Withdrawal Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Alcohol-Induced Disorders, Nervous System
Neurotoxicity Syndromes
Poisoning
Chemically-Induced Disorders
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Substance Withdrawal Syndrome
Ethanol
Etiracetam
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Nootropic Agents