Trial Outcomes & Findings for A Multi-Center Trial of Nepicastat for Cocaine Dependence (NCT NCT01704196)
NCT ID: NCT01704196
Last Updated: 2017-05-18
Results Overview
Number of subjects that abstained from cocaine from weeks 10 through 11
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
179 participants
Primary outcome timeframe
Weeks 10 - 11
Results posted on
2017-05-18
Participant Flow
Participant milestones
| Measure |
Nepicastat
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
|
Placebo
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
89
|
|
Overall Study
COMPLETED
|
71
|
65
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center Trial of Nepicastat for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=89 Participants
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo
|
Total
n=179 Participants
Total of all reporting groups
|
Nepicastat
n=90 Participants
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
75 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=7 Participants
|
179 participants
n=5 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 10 - 11Number of subjects that abstained from cocaine from weeks 10 through 11
Outcome measures
| Measure |
Nepicastat
n=90 Participants
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
|
Placebo
n=89 Participants
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo
|
|---|---|---|
|
Abstinence (Weeks 10 - 11)
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 11Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11
Outcome measures
| Measure |
Nepicastat
n=90 Participants
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
|
Placebo
n=89 Participants
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo
|
|---|---|---|
|
Reduction in Use (Weeks 1 - 11)
|
13 participants
|
20 participants
|
Adverse Events
Nepicastat
Serious events: 8 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nepicastat
n=90 participants at risk
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
|
Placebo
n=89 participants at risk
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo
|
|---|---|---|
|
Cardiac disorders
Hospitalization for Chest Pain
|
0.00%
0/90
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hospitalization for Concussion
|
0.00%
0/90
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Hospitalization for acute pancreatitis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Hospitalization for Congestive Heart Failure
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Atrial Flutter
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Psychiatric disorders
Hospitalization for depression and suicidality
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Skin and subcutaneous tissue disorders
Hospitalization for angioedema secondary to lisinopril
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Hospitalization for head wounds and cracked ribs
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Hospitalization for the flu
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Hospitalization for stab wound
|
1.1%
1/90 • Number of events 1
|
0.00%
0/89
|
Other adverse events
| Measure |
Nepicastat
n=90 participants at risk
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
|
Placebo
n=89 participants at risk
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
6/90 • Number of events 6
|
7.9%
7/89 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
6.7%
6/90 • Number of events 7
|
5.6%
5/89 • Number of events 5
|
|
Nervous system disorders
Headache
|
17.8%
16/90 • Number of events 20
|
12.4%
11/89 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
7/90 • Number of events 8
|
2.2%
2/89 • Number of events 2
|
|
Vascular disorders
Hypertension
|
6.7%
6/90 • Number of events 9
|
7.9%
7/89 • Number of events 9
|
|
Nervous system disorders
Dizziness
|
8.9%
8/90 • Number of events 10
|
7.9%
7/89 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
5/90 • Number of events 6
|
5.6%
5/89 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
5.6%
5/90 • Number of events 5
|
4.5%
4/89 • Number of events 4
|
|
Gastrointestinal disorders
Toothache
|
7.8%
7/90 • Number of events 8
|
4.5%
4/89 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
4/90 • Number of events 5
|
1.1%
1/89 • Number of events 1
|
|
Infections and infestations
Influenza
|
4.4%
4/90 • Number of events 4
|
0.00%
0/89
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
5/90 • Number of events 5
|
10.1%
9/89 • Number of events 10
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/90 • Number of events 2
|
1.1%
1/89 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/90 • Number of events 1
|
2.2%
2/89 • Number of events 3
|
|
Eye disorders
Blurred Vision
|
0.00%
0/90
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
4.4%
4/90 • Number of events 5
|
3.4%
3/89 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place