Trial Outcomes & Findings for Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal (NCT NCT00723177)
NCT ID: NCT00723177
Last Updated: 2016-12-05
Results Overview
Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
Placebo
This group received placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks
|
Low-dose AV411
This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks
|
High-dose AV411
This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
15
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
Low-dose AV411
n=14 Participants
This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
High-dose AV411
n=15 Participants
This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39 Year
STANDARD_DEVIATION 4.5 • n=5 Participants
|
38 Year
STANDARD_DEVIATION 5.3 • n=7 Participants
|
38 Year
STANDARD_DEVIATION 4.3 • n=5 Participants
|
38 Year
STANDARD_DEVIATION 4.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
44 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).Population: Only 30 of the total number of 44 enrolled completed the study .
Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.
Outcome measures
| Measure |
Placebo
n=10 Participants
This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
Low-dose AV411
n=10 Participants
This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
High-dose AV411
n=10 Participants
This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
|---|---|---|---|
|
Subjective Opioid Withdrawal Scale Score (SOWS)
|
16 units on a scale
Standard Error 4
|
4 units on a scale
Standard Error 2
|
24 units on a scale
Standard Error 10
|
SECONDARY outcome
Timeframe: Measured at the end of each AV411 of the three two-week maintenance periodsThe McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.
Outcome measures
| Measure |
Placebo
n=10 Participants
This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
Low-dose AV411
n=10 Participants
This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
High-dose AV411
n=10 Participants
This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
|---|---|---|---|
|
The Effects of AV411 on the Analgesic Effects of Oxycodone.
|
40 units on a scale
Standard Deviation 5
|
42 units on a scale
Standard Deviation 7
|
38 units on a scale
Standard Deviation 5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Low-dose AV411
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High-dose AV411
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
This group will receive placebo AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
Low-dose AV411
n=14 participants at risk
This group will receive a low dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
High-dose AV411
n=15 participants at risk
This group will receive a high dose of AV411
AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
GI upset and Constipation
|
20.0%
3/15 • Number of events 3 • We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
|
14.3%
2/14 • Number of events 4 • We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
|
13.3%
2/15 • Number of events 2 • We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
|
|
Social circumstances
Insomnia
|
13.3%
2/15 • Number of events 3 • We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
|
14.3%
2/14 • Number of events 3 • We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
|
20.0%
3/15 • Number of events 5 • We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place