Trial Outcomes & Findings for Acamprosate Safe to Use in Individuals With Liver Disease. (NCT NCT04287920)

NCT ID: NCT04287920

Last Updated: 2022-12-20

Results Overview

Number of adverse events reported

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2022-12-20

Participant Flow

Participant milestones

Measure	Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months
Overall Study STARTED	6	6
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Acamprosate Safe to Use in Individuals With Liver Disease.

Baseline characteristics by cohort

Measure	Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 n=6 Participants The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 n=6 Participants The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Total n=12 Participants Total of all reporting groups
Age, Continuous	48 years n=5 Participants	50 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: One MELD-NA less than 20 subject and four MELD-NA more than 20 subjects withdrew prior to initiating the study drug. Data was not collected nor analyzed for those 5 subjects

Number of adverse events reported

Outcome measures

Measure	Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 n=5 Participants The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 n=2 Participants The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months
Adverse Event	0 adverse events	1 adverse events

SECONDARY outcome

Timeframe: Baseline, week 24

Population: One MELD-NA less than 20 subject and four MELD-NA more than 20 subjects withdrew prior to initiating the study drug. Data was not collected nor analyzed for those 5 subjects

Number of subjects who experienced a decrease or unchanged Pennsylvania Alcohol Craving Scale (PACS) score from baseline to week 24. Measured using self-reported questionnaire using Pennsylvania Alcohol Craving Scale (PACS). The PACS has 5 questions, where each question has six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher score indicates a positive alcohol craving symptom.

Outcome measures

Measure	Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 n=5 Participants The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 n=2 Participants The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months
Change in Alcohol Craving	3 Participants	1 Participants

Adverse Events

Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alcohol-related Liver Disease and AUD, MELD-NA More Than 20

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 n=6 participants at risk The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months	Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 n=6 participants at risk The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Adverse events were collected from baseline to end of study, approximately 24 weeks.	16.7% 1/6 • Adverse events were collected from baseline to end of study, approximately 24 weeks.

Additional Information

Douglas (Doug) A. Simonetto, M.D.

Mayo Clinic

Phone: 507-284-4824

Email: Simonetto.Douglas@mayo.edu

Results disclosure agreements

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