NCT00627133

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
Last Updated

June 7, 2018

Status Verified

February 1, 2008

Enrollment Period

Same day

First QC Date

February 20, 2008

Last Update Submit

June 5, 2018

Conditions

Seizure, Alcohol Related

Keywords

Alcohol seizure

Outcome Measures

Primary Outcomes (1)

  • Decreased seizures

    1, 2, 4, 8 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: levetiracetam

Interventions

levetiracetamDRUG

2 gram iv load, 500mg bid

1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcohol Withdrawal Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesAlcohol-Induced Disorders, Nervous SystemNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersSubstance Withdrawal Syndrome

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2008

Last Updated

June 7, 2018

Record last verified: 2008-02

Locations

US(1)