Trial Outcomes & Findings for Levetiracetam for the Treatment of Alcohol Dependence and Anxiety (NCT NCT00141115)

Results Overview

Number of participants who reduced drinking during the trial

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

over 9 weeks of study or length of participation

Results posted on

2019-04-24

Participant Flow

Three participants were enrolled into this clinical trial at the New York State Psychiatric Insitute/Columbia University Medical Center.

Participants were enrolled under open-label conditions.

Participant milestones

Participant milestones
Measure	Levetiracetam Levetiracetam 1500 mg BID
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam n=3 Participants Levetiracetam 1500 mg BID
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: over 9 weeks of study or length of participation

Population: Number of participants who were drinking less at the end of the study compared to the beginning.

Number of participants who reduced drinking during the trial

Outcome measures

Outcome measures
Measure	Levetiracetam 1500 mg Twice Daily n=3 Participants Levitiracetam 1500 mg administered twice daily under open-label conditions.
Participants Who Reported Reductions in Alcohol Consumption	3 Participants

SECONDARY outcome

Timeframe: assessed daily, reported for baseline 28 days compared to last 28 days of study participation

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

Outcome measures

Outcome measures
Measure	Levetiracetam 1500 mg Twice Daily n=3 Participants Levitiracetam 1500 mg administered twice daily under open-label conditions.
Percent of Drinking Days Baseline percent of drinking days	67.9 percentage of days Standard Deviation 10.7
Percent of Drinking Days Last 28 days percent of drinking days	27.6 percentage of days Standard Deviation 10.1

Adverse Events

Levetiracetam 1500 mg Twice Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John J. Mariani

New York State Psychiatric Institute

Phone: 2125435987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place