The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
665
Number of Patients With Adverse Events (AEs)
Overview of AEs
Time frame: Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time frame: Baseline to Week 52
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.
Time frame: Baseline and Month 6
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Time frame: Baseline and Month 6
Drinking Risk Level (RSDRL) Response
RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.
Time frame: Month 6
Change From Baseline in Clinical Status Using CGI-S
The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline and Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CZ007
Litoměřice, Czechia
CZ006
Lnáře, Czechia
CZ005
Prague, Czechia
CZ004
Prague, Czechia
CZ001
Ústí nad Labem, Czechia
EE002
Pärnu, Estonia
EE004
Tallinn, Estonia
EE005
Tallinn, Estonia
EE003
Vorumaa, Estonia
EE001
Võru, Estonia
...and 50 more locations
Change in Clinical Status Using the CGI-I
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 24
Liver Function Test Gamma-glutamyl Transferase (GGT)
GGT values
Time frame: Week 24
Liver Function Test Alanine Aminotransferase (ALAT)
ALAT values
Time frame: Week 24
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.
Time frame: Baseline and Month 13
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Time frame: Baseline and Month 13
Drinking Risk Level (RSDRL) Response
RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.
Time frame: Month 13
Change From Baseline in Clinical Status Using CGI-S
The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline and Week 52
Change in Clinical Status Using the CGI-I
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 52
Liver Function Test Gamma-glutamyl Transferase (GGT)
GGT values
Time frame: Week 52
Liver Function Test Alanine Aminotransferase (ALAT)
ALAT values
Time frame: Week 52