Trial Outcomes & Findings for The Effects of Zonisamide on Alcohol Dependence (NCT NCT00406692)

NCT ID: NCT00406692

Last Updated: 2010-05-11

Results Overview

The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2010-05-11

Participant Flow

The recruitment period for this study was from May 2007 to April 2008. The primary forms of recruitment were newspaper advertisement and radio advertisement.

Participant milestones

Measure	Zonisamide 400 mg daily
Overall Study STARTED	16
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Zonisamide 400 mg daily
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

The Effects of Zonisamide on Alcohol Dependence

Baseline characteristics by cohort

Measure	Zonisamide n=16 Participants 400 mg daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: ITT

The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.

Outcome measures

Measure	Zonisamide n=16 Participants 400 mg daily
The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase	-6.7 Standard Drinks Standard Error 1.5

PRIMARY outcome

Timeframe: Week 0- Baseline and Week 12

Population: ITT

Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.

Outcome measures

Measure	Zonisamide n=16 Participants 400 mg daily
Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).	-6.4 Number of Words Standard Error 3.9

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT

Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.

Outcome measures

Measure	Zonisamide n=16 Participants 400 mg daily
Symbol Digit Modalities Test (DSMT)	-1.5 Units on a scale Standard Error 4

Adverse Events

Zonisamide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Zonisamide n=16 participants at risk 400 mg daily
Nervous system disorders Sedation	18.8% 3/16 • Number of events 3 • 13 Weeks

Additional Information

Clifford Knapp, PhD

Boston University

Phone: 617-414-1990

Email: cknapp@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place