- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00627133
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study
June 5, 2018 updated by: Medical University of South Carolina
A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting
Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
2 gram iv load, 500mg bid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decreased seizures
Time Frame: 1, 2, 4, 8 weeks
|
1, 2, 4, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
February 20, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (Estimate)
February 29, 2008
Study Record Updates
Last Update Posted (Actual)
June 7, 2018
Last Update Submitted That Met QC Criteria
June 5, 2018
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- Neurologic Manifestations
- Poisoning
- Alcohol-Induced Disorders
- Neurotoxicity Syndromes
- Alcohol-Induced Disorders, Nervous System
- Substance Withdrawal Syndrome
- Seizures
- Alcohol Withdrawal Seizures
- Anticonvulsants
- Nootropic Agents
- Levetiracetam
Other Study ID Numbers
- K17644
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Seizure, Alcohol Related
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University of New MexicoThe Mind Research NetworkActive, not recruitingAlcohol Drinking | Alcohol Dependence | Alcohol Use Disorder | Alcohol AbuseUnited States
-
National Institute on Alcohol Abuse and Alcoholism...AbbVieCompletedAlcohol Dependence | Alcoholism | Alcohol Use Disorders | Alcohol AbuseUnited States
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Charles Drew University of Medicine and ScienceWithdrawnAlcohol Drinking | Alcohol Use Disorder | Alcohol Abuse | Alcohol Problem
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Boston Medical CenterBoston University; National Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Dependence | Alcohol Abuse | Unhealthy Alcohol Use | Risky Alcohol Consumption Amounts | Hazardous Alcohol UseUnited States
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Kent State UniversityCompletedAlcohol Use Disorder | Alcohol Abuse | Alcohol Abuse, EpisodicUnited States
-
Karolinska InstitutetCompletedAlcohol Drinking | Alcohol Dependence | Alcohol; Harmful Use | Alcohol Use Disorder | Alcohol AbuseSweden
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Karolinska InstitutetRegion Stockholm; Public Health Agency of SwedenCompletedAlcohol Dependence | Alcohol Use Disorder | Alcohol Abuse | Harmful Alcohol UseSweden
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Karolinska InstitutetRegion StockholmCompletedAlcohol Dependence | Alcohol Use Disorder | Alcohol Abuse | Harmful Alcohol UseSweden
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Boston Medical CenterBoston University; National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of PittsburghCompletedAlcohol Dependence | Alcohol ConsumptionUnited States
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Kaiser PermanenteNORC at the University of Chicago; Agency for Healthcare Research and Quality... and other collaboratorsCompleted
Clinical Trials on levetiracetam
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Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
-
UCB Pharma SACompleted
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Odense University HospitalCompleted
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Richard H. HaasThrasher Research FundCompletedSeizures | Disorder of Fetus or NewbornUnited States
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UCB Japan Co. Ltd.CompletedEpilepsies, PartialJapan
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Odense University HospitalCompleted
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Oslo University HospitalUnknownSubclinical Sleep-Activated Epileptiform Activity | CSWSNorway
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National Institute of Mental Health (NIMH)CompletedBipolar DisorderUnited States
-
Odense University HospitalCompleted
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UCB PharmaParexelCompletedHealthy Subjects | Renal ImpairmentsJapan