Efficacy of Keppra in Acute Alcohol Related Seizure Contr... | NCT00627133

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

NCT00627133

Sponsor

Medical University of South Carolina

Status

Withdrawn

Last Update Posted

Jun 7, 2018Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Seizure, Alcohol Related

Interventions

levetiracetam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2008Actual

Completion Date

Not provided

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 28, 2008

First Posted Date

Feb 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2018

Last Update Posted Date

Jun 7, 2018Actual

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: levetiracetam

Name	Type	Description	Arm Group Labels	Other Names
levetiracetam	Drug	2 gram iv load, 500mg bid	1

Measure	Description	Time Frame
Decreased seizures		1, 2, 4, 8 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

Condition Browse Module

MeSH Terms

ID	Term
D020270	Alcohol Withdrawal Seizures

Ancestor Terms

ID	Term
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D020268	Alcohol-Induced Disorders, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077287	Levetiracetam

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided