CirrhosisPhase 3NalmeCirNCT02824354
Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.
A Phase 3 study testing Nalmefene (Selincro®) 18 mg tablet in people with Cirrhosis and Alcohol Dependence, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Alcohol Dependence, Nalmefene
- What is being tested?
- Nalmefene (Selincro®) 18 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient has signed and dated the informed consent form,
- blood alcohol concentration < 0.02% at the screening visit,
- alcohol-dependent patient according to DSM-IV-TR criteria ,
- patient with compensated cirrhosis (cirrhosis demonstrated by clinical and laboratory and/or morphological examinations and/or by a noninvasive test and/or by liver biopsy), Child A or B,
- patient with at least a high drinking risk level (a moderate risk level is defined as a consumption ≥ 60 g of alcohol/day for men and ≥ 40 g of alcohol/day for women),
- male or female, over the age of 18 years, excluding protected majors,
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- patient with a stable address and telephone number,
- name and address of a family member who will be contacted in the event of loss of contact with the patient,
- women of childbearing potential:
- must accept not to become pregnant during the study and,
- must use an effective method of contraception (adequate contraception is defined as oral, systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for the male partner in combination with spermicide) or,
- must have had their last natural menstruation ≥ 24 months before the screening visit or,
- must have been surgically sterilized before the screening visit or,
- must have undergone hysterectomy before the screening visit or,
- must have no sexual activity with a male partner
- patient covered by French national health insurance.
Who cannot join
- cirrhosis Child Pugh C (decompensated cirrhosis)
- cirrhosis complicated by hepatocellular carcinoma or type I or II hepatorenal syndrome or poorly controlled portal hypertension,
- severe acute alcoholic hepatitis, not responding to corticosteroids by the 7th day defined by a Lille model > 0.56 (www.lillemodel.com/score.asp)
- hepatic encephalopathy during the 6 months preceding the screening visit,
- patient with fewer than 6 heavy drinking days during the 4 weeks preceding the screening visit (a heavy drinking day is defined as alcohol consumption of ≥ 60 g/day for men, and ≥ 40 g/day for women),
- patient with at least 14 consecutive days of abstinence during the 4 weeks preceding the screening visit,
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- patient with a CIWA-Ar score (Revised Clinical Institute Withdrawal Assessment for Alcohol) ≥ 10,
- patient with:
- a disorder other than alcohol or nicotine dependence, as evaluated on the MINI (Mini-International Neuropsychiatric Interview)
- antisocial personality disorder evaluated with the MINI questionnaire,
- other disorders for which treatment must take priority to the treatment of alcohol dependence, or which are likely to interfere with the study treatment or compromise adherence to treatment,
- cannabis use does not constitute an exclusion criterion except when it meets the criterion of cannabis dependence
- patient with a suicide risk evaluated using the suicidal tendency module of the MINI (the patient answers "Yes" to one of questions C2, C3, C4, C5 or C6 of the questionnaire),
- patient with a history of delirium tremens or alcohol withdrawal seizures,
- ongoing use of addictive substances other than cannabis, nicotine or benzodiazepines,
- presence of a disorder of comprehension, mental retardation or encephalopathy,
- presence of clinically significant unstable disease (e.g.: renal failure, cardiovascular, pulmonary, gastrointestinal, gastrointestinal, endocrine, neurological, infectious, neoplastic disease or metabolic disorders,
- clinically significant ECG abnormalities,
- history of serious drug allergy or hypersensitivity to nalmefene,
- ongoing or recent treatment (during the 3 months preceding the screening visit) with disulfiram, acamprosate, topiramate, naltrexone, carbimide, or opioid antagonists,
- ongoing or recent treatment (1 week preceding the screening visit) with opioid agonists or partial agonists,
- ongoing or recent treatment (8 weeks preceding the screening visit) with antipsychotics or antidepressants,
- patient taking or who has taken concomitant medications (see supplementary table),
- patient with another disease or taking medications, which, in the investigator's opinion, could interfere with evaluations of safety, tolerability and efficacy,
- treatment with an investigational medicinal product during the 30 days preceding the screening visit,
- ongoing or recent participation (during the 4 weeks preceding the screening visit) in a drinking disorders treatment or support programme, including Alcoholics Anonymous, disintoxication treatment and treatment of alcohol withdrawal symptoms,
- pregnancy or breastfeeding,
- patient who, in the investigator's opinion, has little chance of complying with the protocol or unsuitable for the study for any other reason,
- patient who has already participated in a clinical trial on nalmefene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.
Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.
Read the detailed description
Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption. It appears to be significantly more effective in the group of heavy drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is greater than 120 g/day.
No data are available concerning nalmefene in alcohol-dependent patients with alcoholic cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy drinking in patients with alcoholic cirrhosis, with potential improvement of liver function. No comparator is available for nalmefene, as all other molecules require abstinence prior to starting treatment.
- Conditions
- Cirrhosis, Alcohol Dependence, Nalmefene
- Being tested
- Nalmefene (Selincro®) 18 mg tablet, placebo
- Medical subject headings
- Fibrosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene (Selincro®) 18 mg tabletDrug
Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.
placeboDrug
Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The placebo will have the same composition as the active treatment (without the drug substance) and an identical appearance. White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. Receives: Drug: placebo |
| Nalmefene | Experimental | Drug : 'Nalmefene (Selincro®) 18 mg tablet is a white, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. It contains 18.06 mg nalmefene (in the form of hydrochloride dihydrate).
Nalmefene must be taken as-needed: on each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking nalmefene, the patient should take one tablet as soon as possible.
The maximum dose of nalmefene is one tablet per day. Nalmefene can be taken with or without food. Receives: Drug: Nalmefene (Selincro®) 18 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the number of monthly heavy drinking days after 6 months of treatment compared to baseline.
Measured: 6 months
Secondary outcomes (4)
The number of non-drinking days during the treatment period; nalmefene arm versus placebo arm,
Measured: 6 months
Evaluation of craving; nalmefene arm responders versus nalmefene arm non-responders
Severity of Alcohol Dependence Questionnaire, Obsessive Compulsive Drinking Scale
Measured: 6 months
Course of liver function after 6 months of treatment compared to baseline
- Course of liver function after 6 months of treatment compared to baseline:
- nalmefene arm versus placebo arm, nalmefene arm responders versus nalmefene arm non-responders : - nalmefene arm versus placebo arm; - nalmefene arm responders versus nalmefene arm non-responders, PT, Bilirubin, ALT, GGT, Albumin, Creatinine. MELD and Child-Pugh scores
Measured: 6 months
6 months survival
6-month survival: nalmefene arm versus placebo arm; nalmefene arm responders versus nalmefene arm non-responders
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start1 Dec 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric NGUYEN-KHAC, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824354
- Sponsor's protocol ID
- PI2015_843_0017
- Acronym
- NalmeCir
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2016
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.
- ClinicalTrials.gov ID
- NCT02824354
- Acronym / sponsor ID
- NalmeCir / PI2015_843_0017
- Conditions
- Cirrhosis, Alcohol Dependence, Nalmefene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.
Detailed description
Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption. It appears to be significantly more effective in the group of heavy drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is greater than 120 g/day.
No data are available concerning nalmefene in alcohol-dependent patients with alcoholic cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy drinking in patients with alcoholic cirrhosis, with potential improvement of liver function. No comparator is available for nalmefene, as all other molecules require abstinence prior to starting treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboThe placebo will have the same composition as the active treatment (without the drug substance) and an identical appearance. White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. |
| Nalmefene | Experimental | Drug: Nalmefene (Selincro®) 18 mg tabletDrug : 'Nalmefene (Selincro®) 18 mg tablet is a white, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. It contains 18.06 mg nalmefene (in the form of hydrochloride dihydrate). Nalmefene must be taken as-needed: on each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking nalmefene, the patient should take one tablet as soon as possible. The maximum dose of nalmefene is one tablet per day. Nalmefene can be taken with or without food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- the patient has signed and dated the informed consent form,
- blood alcohol concentration < 0.02% at the screening visit,
- alcohol-dependent patient according to DSM-IV-TR criteria ,
- patient with compensated cirrhosis (cirrhosis demonstrated by clinical and laboratory and/or morphological examinations and/or by a noninvasive test and/or by liver biopsy), Child A or B,
- patient with at least a high drinking risk level (a moderate risk level is defined as a consumption ≥ 60 g of alcohol/day for men and ≥ 40 g of alcohol/day for women),
Key exclusion criteria (29 listed)
- cirrhosis Child Pugh C (decompensated cirrhosis)
- cirrhosis complicated by hepatocellular carcinoma or type I or II hepatorenal syndrome or poorly controlled portal hypertension,
- severe acute alcoholic hepatitis, not responding to corticosteroids by the 7th day defined by a Lille model > 0.56 (www.lillemodel.com/score.asp)
- hepatic encephalopathy during the 6 months preceding the screening visit,
- patient with fewer than 6 heavy drinking days during the 4 weeks preceding the screening visit (a heavy drinking day is defined as alcohol consumption of ≥ 60 g/day for men, and ≥ 40 g/day for women),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalmefene (Selincro®) 18 mg tabletEvaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis. | Drug | Nalmefene |
| placeboEvaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis. | Drug | placebo |
Primary outcome
Reduction of the number of monthly heavy drinking days after 6 months of treatment compared to baseline.
Time frame: 6 months
4 secondary outcomes
The number of non-drinking days during the treatment period; nalmefene arm versus placebo arm,
Time frame: 6 months
Evaluation of craving; nalmefene arm responders versus nalmefene arm non-responders
Time frame: 6 months
Course of liver function after 6 months of treatment compared to baseline
Time frame: 6 months
6 months survival
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric NGUYEN-KHAC, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nalmefene (Selincro®) 18 mg tablet in people with Cirrhosis and Alcohol Dependence, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the number of monthly heavy drinking days after 6 months of treatment compared to baseline. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.