Trial Outcomes & Findings for Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence (NCT NCT02120365)
NCT ID: NCT02120365
Last Updated: 2023-08-18
Results Overview
A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This outcome item reports the Stimulant Subscale results analyzed with mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "excited"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
98 minutes
Results posted on
2023-08-18
Participant Flow
random assignment. Crossover
Participant milestones
| Measure |
Placebo, Then Perampanel 6mg, Then Perampanel 10mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target Breath Alcohol Concentration (BrAC) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA)-Receptor that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Placebo, Then Perampanel 10mg, Then Perampanel 6mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 6mg, Then Placebo, Then Perampanel 10mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 6mg, Then Perampanel 10mg, Then Placebo
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 10mg, Then Perampanel 6mg, Then Placebo
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 10mg, Then Placebo, Then Perampanel 6mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg 7 days prior to each test day, and then observed dosing of high dose perampanel (10mg) in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
4
|
3
|
2
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
0
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
4
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo, Then Perampanel 6mg, Then Perampanel 10mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target Breath Alcohol Concentration (BrAC) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA)-Receptor that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Placebo, Then Perampanel 10mg, Then Perampanel 6mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 6mg, Then Placebo, Then Perampanel 10mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 6mg, Then Perampanel 10mg, Then Placebo
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 10mg, Then Perampanel 6mg, Then Placebo
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses \[target BrAc (Breath Alcohol Concentration) =20mg%, 60mg%, and 100mg%\] in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 10mg, Then Placebo, Then Perampanel 6mg
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg 7 days prior to each test day, and then observed dosing of high dose perampanel (10mg) in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
4
|
0
|
2
|
Baseline Characteristics
Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Combined Group Crossover Study - Placebo/6mg/10mg
n=22 Participants
Crossover design with all participants completing three conditions. Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 98 minutesPopulation: Non-treatment Seeking Heavy Drinkers of whom all participated in three separate lab days, each following a different dose of perampanel or placebo.
A 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This outcome item reports the Stimulant Subscale results analyzed with mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "excited"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).
Outcome measures
| Measure |
Placebo Medication Dose
n=14 Participants
This is the mean effect of the placebo dose on BAES Stimulant Subscale
|
Perampanel 6mg Dose
n=17 Participants
This is the mean score of the 6mg dose of perampanel on the BAES Stimulant Subscale
|
Perampanel 10mg Dose
n=15 Participants
This is the effect of the mean of the perampanel 10mg dose on the BAES Stimulant Subscale
|
|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES): Stimulant Subscale
|
13.756 score on a scale
Standard Error 2.747
|
14.053 score on a scale
Standard Error 2.658
|
13.026 score on a scale
Standard Error 2.816
|
PRIMARY outcome
Timeframe: 98 minutesA 14-item scale with 7 items designed to assess stimulant effects from alcohol intoxication and 7 items developed to measure the sedative effects of alcohol. This scale was selected as a primary outcome measure because it is sensitive to the effect of alcohol. This entry item show the results for the sedative subscale evaluated in mixed models. Each item can be scored a minimum of zero (0) or up to 10 with the 10 representing feeling more or the most intoxicated in that item's description (e.g., "sedated"). The minimum score is 0 and the maximum score is 70. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).
Outcome measures
| Measure |
Placebo Medication Dose
n=14 Participants
This is the mean effect of the placebo dose on BAES Stimulant Subscale
|
Perampanel 6mg Dose
n=17 Participants
This is the mean score of the 6mg dose of perampanel on the BAES Stimulant Subscale
|
Perampanel 10mg Dose
n=15 Participants
This is the effect of the mean of the perampanel 10mg dose on the BAES Stimulant Subscale
|
|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES)- Sedative Subscale
|
4.624 score on a scale
Standard Deviation 1.784
|
7.159 score on a scale
Standard Deviation 1.649
|
10.263 score on a scale
Standard Deviation 1.797
|
PRIMARY outcome
Timeframe: 98 minconsists of four items that measure current alcohol effects: 'feel alcohol', 'feel high', 'like alcohol', and 'want more alcohol'. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). There are five items on the scale with scores of 0 to 100, and the total score is used by averaging all five items, thus, the minimum total score on the scale is 0 and the maximum is 100. The lowest score 0 represents "not at all" or not experiencing any drug effects from alcohol, and 100 represents "extremely" experiencing alcohol effects.
Outcome measures
| Measure |
Placebo Medication Dose
n=14 Participants
This is the mean effect of the placebo dose on BAES Stimulant Subscale
|
Perampanel 6mg Dose
n=17 Participants
This is the mean score of the 6mg dose of perampanel on the BAES Stimulant Subscale
|
Perampanel 10mg Dose
n=15 Participants
This is the effect of the mean of the perampanel 10mg dose on the BAES Stimulant Subscale
|
|---|---|---|---|
|
Drug Effects Questionaire (DEQ)
|
42.538 score on a scale
Standard Error 3.379
|
40.619 score on a scale
Standard Error 3.269
|
43.267 score on a scale
Standard Error 3.442
|
SECONDARY outcome
Timeframe: 98 minA valid eight-item Likert-type scale designed to assess acute alcohol craving. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving. The minimum score is 7, and the maximum is 49. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).
Outcome measures
| Measure |
Placebo Medication Dose
n=14 Participants
This is the mean effect of the placebo dose on BAES Stimulant Subscale
|
Perampanel 6mg Dose
n=17 Participants
This is the mean score of the 6mg dose of perampanel on the BAES Stimulant Subscale
|
Perampanel 10mg Dose
n=15 Participants
This is the effect of the mean of the perampanel 10mg dose on the BAES Stimulant Subscale
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ)
|
16.481 score on a scale
Standard Error 1.266
|
17.314 score on a scale
Standard Error 1.177
|
18.723 score on a scale
Standard Error 1.289
|
SECONDARY outcome
Timeframe: 98 minutesPopulation: Non-Treatment Seeking Heavy Drinkers
This consists of a list of side effects associated with perampanel (e.g., fatigue, dizziness), rated from 0="none" to 4="severe". The mean for each subject across all items is included in each group/arm mean. The lowest score on the scale would be 0 and the maximum 4, as the mean across items is taken and not a sum. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes).
Outcome measures
| Measure |
Placebo Medication Dose
n=14 Participants
This is the mean effect of the placebo dose on BAES Stimulant Subscale
|
Perampanel 6mg Dose
n=17 Participants
This is the mean score of the 6mg dose of perampanel on the BAES Stimulant Subscale
|
Perampanel 10mg Dose
n=15 Participants
This is the effect of the mean of the perampanel 10mg dose on the BAES Stimulant Subscale
|
|---|---|---|---|
|
Side Effect Questionnaire (SEQ)
|
0.895 score on a scale
Standard Error .294
|
.992 score on a scale
Standard Error .261
|
1.13 score on a scale
Standard Error .280
|
SECONDARY outcome
Timeframe: 98 minutesPopulation: Nontreatment-seeking Heavy Drinkers (NTSHDs)
The Profile of Mood States (POMS) 2 short version contains a subset of 35 items from the full-length versions. This subset comprises those five items on full version POMS scale that exhibited good item-total correlations and best predicted their respective scale scores, this is a TOTAL score Representing total mood disturbance. For the time frame, the values at different time points were combined (averaged) into a single value that represents the effect during the time interval of interest (12 to 110 minutes). The minimum is 0 and the maximum is 100 with higher numbers indicating greater mood disturbance.
Outcome measures
| Measure |
Placebo Medication Dose
n=14 Participants
This is the mean effect of the placebo dose on BAES Stimulant Subscale
|
Perampanel 6mg Dose
n=17 Participants
This is the mean score of the 6mg dose of perampanel on the BAES Stimulant Subscale
|
Perampanel 10mg Dose
n=15 Participants
This is the effect of the mean of the perampanel 10mg dose on the BAES Stimulant Subscale
|
|---|---|---|---|
|
Profile of Mood States (POMS) 2 Short Version Total Score
|
20.25 score on a scale
Standard Error 1.490
|
21.75 score on a scale
Standard Error 1.335
|
20.619 score on a scale
Standard Error 1.533
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Perampanel 6mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Perampanel 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg days prior to each test day, and then observed dosing moderate 6mg dose perampanel in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
|
Perampanel 6mg
n=22 participants at risk
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with placebo 7 days prior to each test day, and then observed dosing of placebo in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.
Placebo: Placebo given in place of perampanel during the pre-treatment period and lab session days.
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Perampanel 10 mg
n=22 participants at risk
Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg 7 days prior to each test day, and then observed dosing of high dose perampanel (10mg) in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.
Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
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|---|---|---|---|
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Gastrointestinal disorders
nausea/vomiting
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
9.1%
2/22 • Number of events 2 • 40 days of participation
|
|
Skin and subcutaneous tissue disorders
IV site bruising/thrombosis
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
|
Infections and infestations
Viral cold symptoms
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
|
Renal and urinary disorders
dysuria
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/22 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
|
Psychiatric disorders
Fatigue
|
0.00%
0/22 • 40 days of participation
|
0.00%
0/22 • 40 days of participation
|
4.5%
1/22 • Number of events 1 • 40 days of participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place