Alcohol dependence MedDRA version: 9.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome
Conditions
Interventions
Product Name: Nalmefene
Product Code: Lu AA 36143
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NALMEFENE
CAS Number: 55096269
Current Sponsor code: Lu AA36143
Other descriptive name: N
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to read and understand the Subject Information Sheet. 2. The patient has signed the Informed Consent Form. 3. The patient has a BAC of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has less than 6 heavy drinking days (HDD) in the 4 weeks preceding the screening visit. A HDD is defined as a day of alcohol consumption with 60 g or more for males and 40 g or more for females. 2. The patient has more than 14 consecutive abstinent days in the 4 weeks preceding the screening visit. 3. The patient has a CIWA-Ar score of 10 or more. 4. The patient has a severe psychiatric disorder (such as psychosis, schizophrenia, severe depression, eating disorders, bipolar disorder), antisocial personality disorder or other disorders for which the treatment takes priority over treatment of the drinking problem, or is likely to interfere with study treatment or impairs treatment compliance. 5. The patient has risk of suicide evaluated by the suicidality module of MINI (the patient answers ‘yes’ to any of the questions C2, C3, C4, C5, or C6). 6. The patient has a history of delirium tremens or alcohol withdrawal seizures. 7. The patient has a cognitive impairment which judged by the investigator is likely to interfere with the patient’s understanding of the study and its procedures. 8. The patient reports or urine drug screen reveals current use of substances of abuse other than alcohol, cannabis, nicotine or benzodiazepines. 9. The patient has seizure disorder, mental retardation, or encephalopathy in the medical history. 10. The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance. 11. The patient has clinically significant abnormal vital signs. 12. The patient has S-ASAT and/or S-ALAT levels greater than 3 times of upper normal limit, or one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant. 13. The patient has clinically significant abnormal findings in ECG. 14. The patient has a history of severe drug allergy or hypersensitivity. 15. The patient reports current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists. 16. The patient reports current or recent (within 1 week preceding screening) treatment with opioid agonists or partial agonists. 17. The patient used/uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant Medication) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. 18. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy. 19. The patient is currently participating or has recently (4 weeks prior to the screening visit) participated in a treatment or support programme for alcohol use disorders, including Alcohol Anonymous, detoxification treatment and treatment of alcohol withdrawal symptoms. 20. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening. 21. The patient is pregnant or breast-feeding. 22. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. 23. The patient is a member of the site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: o Safety: - To evaluate the long term safety and tolerability of as needed use of 20 mg nalmefene versus placebo over a period of 52 weeks in patients with alcohol dependence. o Efficacy: - To evaluate the effect of as needed use of 20 mg nalmefene on alcohol consumption by the monthly number of heavy drinking days (HDD) and the monthly total consumption in patients with alcohol dependence during a treatment period of 24 weeks (co-primary efficacy endpoints);Secondary Objective: o To evaluate the effect of as needed use of 20 mg nalmefene in patients with alcohol dependence during a treatment period of 24 weeks, on: - proportion of responders based on drinking measures - alcohol dependence symptoms and clinical status - liver function and other biological laboratory tests - pharmacoeconomic outcomes o To evaluate the long-term therapeutic effect of as needed use of 20 mg nalmefene versus placebo over a period of 52 weeks in patients with alcohol dependence, on: - reduction of alcohol consumption - alcohol dependence symptoms and clinical status - liver function and other biological tests - pharmacoeconomic outcomes o To explore how genotype may affect treatment response to nalmefene;Primary end point(s): Safety will be evaluated by adverse events (AEs), clinical safety laboratory tests, vital signs, weight, electrocardiograms (ECGs), physical examinations and POMS scale. The therapeutic effect on the reduction of alcohol consumption will be evaluated by number of HDD, total consumption, DrInC, CGI-I, CGI-S, GGT, ALAT, CDT and MCV. | — |
Countries
Czech Republic, Estonia, Hungary, Latvia, Lithuania, United Kingdom
Outcome results
None listed