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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Medical University of South Carolina.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00627133
First received: February 20, 2008
Last updated: October 23, 2008
Last verified: February 2008
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
Experimental: 1 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
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: 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

No publications provided

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

Keywords provided by Medical University of South Carolina:
Alcohol seizure

Additional relevant MeSH terms:
Alcohol Withdrawal Seizures
Seizures
Alcohol-Induced Disorders
Alcohol-Induced Disorders, Nervous System
Alcohol-Related Disorders
Brain Diseases
Central Nervous System Diseases
Chemically-Induced Disorders
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Neurotoxicity Syndromes
Poisoning
Signs and Symptoms
Substance Withdrawal Syndrome
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 20, 2014