Trial Outcomes & Findings for Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition (NCT NCT02534038)
NCT ID: NCT02534038
Last Updated: 2020-10-26
Results Overview
TERMINATED
PHASE2
1 participants
Baseline; Week 6, Week 8, and Week 14
2020-10-26
Participant Flow
Participant milestones
| Measure |
AVP-786; Placebo
In Period 1, participants were randomized to receive AVP-786 (deuterated \[d6\]-dextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) once a day (OD) in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 twice a day (BID) for 14 days. From Day 22, participants received a target dose of d6-DM 28 milligrams (mg)/Q 4.9 mg (AVP-786-28/4.9) BID for the remaining 3 weeks of Period 1. In Period 2, participants were randomized to receive matching placebo. The periods were separated by a 2-week washout period.
|
Placebo; AVP-786
In Period 1, participants were randomized to receive matching placebo. In Period 2, participants were randomized to receive AVP-786 OD in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 BID for 14 days. From Day 22, participants received a target dose of AVP-786-28/4.9 BID for the remaining 3 weeks of Period 2. The periods were separated by a 2-week washout period.
|
|---|---|---|
|
Period 1 (6 Weeks)
STARTED
|
1
|
0
|
|
Period 1 (6 Weeks)
COMPLETED
|
1
|
0
|
|
Period 1 (6 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (6 Weeks)
STARTED
|
1
|
0
|
|
Period 2 (6 Weeks)
COMPLETED
|
1
|
0
|
|
Period 2 (6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Baseline characteristics by cohort
| Measure |
AVP-786; Placebo
n=1 Participants
In Period 1, participants were randomized to receive AVP-786 (deuterated \[d6\]-dextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) once a day (OD) in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 twice a day (BID) for 14 days. From Day 22, participants received a target dose of d6-DM 28 milligrams (mg)/Q 4.9 mg (AVP-786-28/4.9) BID for the remaining 3 weeks of Period 1. In Period 2, participants were randomized to receive matching placebo. The periods were separated by a 2-week washout period.
|
Placebo; AVP-786
In Period 1, participants were randomized to receive matching placebo. In Period 2, participants were randomized to receive AVP-786 OD in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 BID for 14 days. From Day 22, participants received a target dose of AVP-786-28/4.9 BID for the remaining 3 weeks of Period 2. The periods were separated by a 2-week washout period.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
—
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 3, Week 6, Week 11, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 3, Week 6, Week 11, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 6, Week 8, and Week 14Population: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
AVP-786
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=1 participants at risk
Participants received matching placebo for 6 weeks.
|
AVP-786
n=1 participants at risk
Participants received AVP-786 (up to a target dose of d6-DM 28 milligrams \[mg\]/Q 4.9 mg \[AVP-786-28/4.9\] twice a day \[BID\]) for 6 weeks.
|
|---|---|---|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • up to 22 weeks
|
100.0%
1/1 • up to 22 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • up to 22 weeks
|
100.0%
1/1 • up to 22 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER