Trial Outcomes & Findings for ABT-436 for Alcohol Dependence (NCT NCT01613014)

Last Updated: 2017-04-04

Results Overview

The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days (reduction in drinking) in subjects with alcohol dependence confirmed by DSM-IV-TR criteria. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. The outcome measure was averaged across weeks 2-12.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

Weeks 2-12

Results posted on

2017-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Sugar Pill Matched Placebo sugar pill - target dose 2 pills BID Matched Placebo - Sugar Pill: Target Dose - 2 pills BID	ABT-436 ABT-436 Target dose of 400 mg BID ABT-436: Target dose - 400mg BID
Overall Study STARTED	75	75
Overall Study COMPLETED	57	63
Overall Study NOT COMPLETED	18	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABT-436 for Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=71 Participants Matched Placebo sugar pill - target dose 2 pills BID Matched Placebo - Sugar Pill: Target Dose - 2 pills BID	ABT-436 n=73 Participants ABT-436 Target dose of 400 mg BID ABT-436: Target dose - 400mg BID	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=39 Participants	73 Participants n=41 Participants	144 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	45.5 years STANDARD_DEVIATION 11.6 • n=39 Participants	45.8 years STANDARD_DEVIATION 10.2 • n=41 Participants	45.7 years STANDARD_DEVIATION 10.9 • n=35 Participants
Sex: Female, Male Female	25 Participants n=39 Participants	27 Participants n=41 Participants	52 Participants n=35 Participants
Sex: Female, Male Male	46 Participants n=39 Participants	46 Participants n=41 Participants	92 Participants n=35 Participants
Region of Enrollment United States	71 participants n=39 Participants	73 participants n=41 Participants	144 participants n=35 Participants

PRIMARY outcome

Timeframe: Weeks 2-12

Population: Models are based on a mITT population that included subjects who received at least one dose of medication (N=144; ABT-436=73, placebo=71). One additional placebo subject had no drinking data during the maintenance period, and one ABT-436 subject was missing data on a baseline covariate, resulting in an analyzable N=142 (ABT-436=72, placebo=70).

Outcome measures

Outcome measures
Measure	Sugar Pill n=70 Participants Matched Placebo sugar pill - target dose 2 pills BID Matched Placebo - Sugar Pill: Target Dose - 2 pills BID	ABT-436 n=72 Participants ABT-436 Target dose of 400 mg BID ABT-436: Target dose - 400mg BID
Weekly Percentage of Heaving Drinking Days	37.6 weekly percentage of heavy drinking days Interval 29.2 to 45.9	31.3 weekly percentage of heavy drinking days Interval 23.4 to 39.2

Adverse Events

Sugar Pill

Serious events: 1 serious events

Other events: 67 other events

Deaths: 0 deaths

ABT-436

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugar Pill n=71 participants at risk Matched Placebo sugar pill - target dose 2 pills BID Matched Placebo - Sugar Pill: Target Dose - 2 pills BID	ABT-436 n=73 participants at risk ABT-436 Target dose of 400 mg BID ABT-436: Target dose - 400mg BID
Infections and infestations Cellulitis	0.00% 0/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	1.4% 1/73 • Number of events 1 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Cardiac disorders Atrial Fibrillation	0.00% 0/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	1.4% 1/73 • Number of events 1 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Peptic Ulcer	1.4% 1/71 • Number of events 1 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	0.00% 0/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.

Other adverse events

Additional Information

Megan Ryan, Clinical Program Director

NIAAA

Phone: 3014434225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sugar Pill n=71 participants at risk Matched Placebo sugar pill - target dose 2 pills BID Matched Placebo - Sugar Pill: Target Dose - 2 pills BID	ABT-436 n=73 participants at risk ABT-436 Target dose of 400 mg BID ABT-436: Target dose - 400mg BID
Gastrointestinal disorders Diarrhoea	19.7% 14/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	50.7% 37/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Nervous system disorders Headache	25.4% 18/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	23.3% 17/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Nausea	12.7% 9/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	24.7% 18/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Nasopharyngitis	7.0% 5/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	11.0% 8/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Infections and infestations Upper respiratory tract infection	11.3% 8/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Blood and lymphatic system disorders Blood Creatine Phosphokinase	8.5% 6/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	9.6% 7/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Vomiting	7.0% 5/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	9.6% 7/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Nervous system disorders Dizziness	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	9.6% 7/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Musculoskeletal and connective tissue disorders Back Pain	4.2% 3/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	9.6% 7/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Dyspepsia	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
General disorders Irritability	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Investigations Eosinophil Count increased	4.2% 3/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	8.2% 6/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 5/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Psychiatric disorders Disorientation	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Abdominal Distension	2.8% 2/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Abdominal Pain	2.8% 2/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Constipation	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	4.1% 3/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Musculoskeletal and connective tissue disorders Myalgia	4.2% 3/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Skin and subcutaneous tissue disorders Rash	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	4.1% 3/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Gastrointestinal disorders Flatulence	2.8% 2/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Infections and infestations Rhinitis	1.4% 1/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Immune system disorders Neutrophil Count Increased	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	2.7% 2/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Investigations Red blood cells urine positive	2.8% 2/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Psychiatric disorders Anxiety	0.00% 0/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	6.8% 5/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Skin and subcutaneous tissue disorders Pruritus	5.6% 4/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	1.4% 1/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
General disorders Asthenia	0.00% 0/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/71 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.	5.5% 4/73 The sample size for the adverse event table is 144 which is the mITT population - subjects who took at least one dose of medication.