Trial Outcomes & Findings for A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence (NCT NCT02382276)
NCT ID: NCT02382276
Last Updated: 2020-07-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
24-week treatment period
Results posted on
2020-07-20
Participant Flow
Participant milestones
| Measure |
Nalmefene 20 mg in the lead-in Study
Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Nalmefene 10 mg in the lead-in Study
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Placebo in the lead-in Study
Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
137
|
94
|
172
|
|
Overall Study
COMPLETED
|
126
|
84
|
133
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
39
|
Reasons for withdrawal
| Measure |
Nalmefene 20 mg in the lead-in Study
Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Nalmefene 10 mg in the lead-in Study
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Placebo in the lead-in Study
Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
5
|
|
Overall Study
Adverse Event
|
7
|
2
|
32
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
Baseline Characteristics
Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
Baseline characteristics by cohort
| Measure |
Nalmefene 20 mg in the lead-in Study
n=137 Participants
Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Nalmefene 10 mg in the lead-in Study
n=94 Participants
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Placebo in the lead-in Study
n=172 Participants
Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=137 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=403 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=137 Participants
|
85 Participants
n=94 Participants
|
154 Participants
n=172 Participants
|
359 Participants
n=403 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=137 Participants
|
9 Participants
n=94 Participants
|
18 Participants
n=172 Participants
|
44 Participants
n=403 Participants
|
|
Age, Customized
|
50.0 years
STANDARD_DEVIATION 11.7 • n=137 Participants
|
50.1 years
STANDARD_DEVIATION 11.0 • n=94 Participants
|
48.5 years
STANDARD_DEVIATION 11.0 • n=172 Participants
|
49.4 years
STANDARD_DEVIATION 11.2 • n=403 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=137 Participants
|
19 Participants
n=94 Participants
|
64 Participants
n=172 Participants
|
116 Participants
n=403 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=137 Participants
|
75 Participants
n=94 Participants
|
108 Participants
n=172 Participants
|
287 Participants
n=403 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
137 Participants
n=137 Participants
|
94 Participants
n=94 Participants
|
172 Participants
n=172 Participants
|
403 Participants
n=403 Participants
|
|
Region of Enrollment
Japan
|
137 Participants
n=137 Participants
|
94 Participants
n=94 Participants
|
172 Participants
n=172 Participants
|
403 Participants
n=403 Participants
|
|
Heavy Drinking Days (HDDs)
|
22.54 days/month
STANDARD_DEVIATION 6.70 • n=137 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
24.38 days/month
STANDARD_DEVIATION 5.10 • n=94 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
22.70 days/month
STANDARD_DEVIATION 6.54 • n=169 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
23.04 days/month
STANDARD_DEVIATION 6.32 • n=400 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
|
Total Alcohol Consumption (TAC)
|
94.10 g/day
STANDARD_DEVIATION 34.43 • n=137 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
94.16 g/day
STANDARD_DEVIATION 32.60 • n=94 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
92.30 g/day
STANDARD_DEVIATION 41.03 • n=169 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
93.35 g/day
STANDARD_DEVIATION 36.90 • n=400 Participants • Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
|
PRIMARY outcome
Timeframe: 24-week treatment periodPopulation: Safety analysis set, which included all patients who received at least one dose of study medication during the 24-week treatment period in the extension study.
Outcome measures
| Measure |
Nalmefene 20 mg in the lead-in Study
n=137 Participants
Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Nalmefene 10 mg in the lead-in Study
n=94 Participants
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Placebo in the lead-in Study
n=172 Participants
Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
96 Number of participants
|
67 Number of participants
|
141 Number of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
Outcome measures
| Measure |
Nalmefene 20 mg in the lead-in Study
n=137 Participants
Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Nalmefene 10 mg in the lead-in Study
n=94 Participants
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Placebo in the lead-in Study
n=169 Participants
Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
|---|---|---|---|
|
Change in the Number of Heavy Drinking Days (HDDs) From Baseline
|
-15.09 days/month
Standard Error 0.77
|
-17.15 days/month
Standard Error 0.94
|
-16.35 days/month
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study.
Outcome measures
| Measure |
Nalmefene 20 mg in the lead-in Study
n=137 Participants
Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Nalmefene 10 mg in the lead-in Study
n=94 Participants
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
Placebo in the lead-in Study
n=169 Participants
Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period.
|
|---|---|---|---|
|
Change in Total Alcohol Consumption (TAC) From Baseline
|
-53.20 g/day
Standard Error 2.29
|
-57.93 g/day
Standard Error 2.77
|
-55.77 g/day
Standard Error 2.06
|
Adverse Events
Total
Serious events: 3 serious events
Other events: 209 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total
n=403 participants at risk
Nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period in the extension study
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/403 • Number of events 1 • 24-week treatment period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/403 • Number of events 1 • 24-week treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/403 • Number of events 1 • 24-week treatment period
|
Other adverse events
| Measure |
Total
n=403 participants at risk
Nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period in the extension study
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.7%
23/403 • 24-week treatment period
|
|
Gastrointestinal disorders
Nausea
|
19.6%
79/403 • 24-week treatment period
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
25/403 • 24-week treatment period
|
|
General disorders
Malaise
|
6.5%
26/403 • 24-week treatment period
|
|
Infections and infestations
Nasopharyngitis
|
15.4%
62/403 • 24-week treatment period
|
|
Nervous system disorders
Dizziness
|
9.7%
39/403 • 24-week treatment period
|
|
Nervous system disorders
Headache
|
7.2%
29/403 • 24-week treatment period
|
|
Nervous system disorders
Somnolence
|
6.5%
26/403 • 24-week treatment period
|
|
Psychiatric disorders
Insomnia
|
5.0%
20/403 • 24-week treatment period
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place