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Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

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ClinicalTrials.gov Identifier: NCT00141115
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : September 15, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alcoholism
Generalized Anxiety Disorder
Panic Disorder
Social Phobia
Anxiety Disorders
Intervention Drug: levetiracetam
Enrollment 3
Recruitment Details Three participants were enrolled into this clinical trial at the New York State Psychiatric Insitute/Columbia University Medical Center.
Pre-assignment Details Participants were enrolled under open-label conditions.
Arm/Group Title Levetiracetam
Hide Arm/Group Description Levetiracetam 1500 mg BID
Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Arm/Group Title Levetiracetam
Hide Arm/Group Description Levetiracetam 1500 mg BID
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
1.Primary Outcome
Title Participants Who Reported Reductions in Alcohol Consumption
Hide Description Number of participants who reduced drinking during the trial
Time Frame over 9 weeks of study or length of participation
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who were drinking less at the end of the study compared to the beginning.
Arm/Group Title Levetiracetam 1500 mg Twice Daily
Hide Arm/Group Description:
Levitiracetam 1500 mg administered twice daily under open-label conditions.
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
2.Secondary Outcome
Title Percent of Drinking Days
Hide Description daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back
Time Frame assessed daily, reported for baseline 28 days compared to last 28 days of study participation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Levetiracetam 1500 mg BID

levetiracetam: Levetiracetam 1500 mg BID

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: percentage of days
Baseline percent of drinking days 67.9  (10.7)
Last 28 days percent of drinking days 27.6  (10.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam 1500 mg Twice Daily
Hide Arm/Group Description Levitiracetam 1500 mg administered twice daily under open label conditions.
All-Cause Mortality
Levetiracetam 1500 mg Twice Daily
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam 1500 mg Twice Daily
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levetiracetam 1500 mg Twice Daily
Affected / at Risk (%)
Total   0/3 (0.00%) 
poor recruitment leading to small number of participants in the analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John J. Mariani
Organization: New York State Psychiatric Institute
Phone: 2125435987
EMail: jm2330@columbia.edu
Layout table for additonal information
Responsible Party: John Mariani MD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00141115     History of Changes
Other Study ID Numbers: 4773
First Submitted: August 31, 2005
First Posted: September 1, 2005
Results First Submitted: November 26, 2012
Results First Posted: September 15, 2017
Last Update Posted: April 24, 2019