Trial Outcomes & Findings for The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects (NCT NCT00329407)

Results Overview

The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

70 days

Results posted on

2010-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	Topiramate Treatment In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Topiramate Treatment In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate Treatment n=10 Participants In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	50.7 years STANDARD_DEVIATION 8.9 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment United States	10 participants n=99 Participants

PRIMARY outcome

Timeframe: 70 days

Population: An ITT approach was used in the analysis. Least squares value for the baseline and 10 week of treatment were compared using a t test with Dunnett-Hsu adjustment. Differences between these means are presented as the result.

The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.

Outcome measures

Outcome measures
Measure	Topiramate Treatment n=10 Participants In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method	-4.9 Standard Drink (14 g alcohol) Standard Error 0.86

SECONDARY outcome

Timeframe: Baseline compared to Week 10

Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores

Outcome measures

Outcome measures
Measure	Topiramate Treatment n=10 Participants In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
Phonetic Portion of the Controlled Word Association Test (COWAT)	-11 Number of words Standard Error 2.7

Adverse Events

Topiramate Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Topiramate Treatment n=10 participants at risk In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
Nervous system disorders Agitation and Impaired Concentration	20.0% 2/10 • Number of events 2

Additional Information

Ofra sarid-Segal, MD

Boston University

Phone: 617-414-1990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place