Trial Outcomes & Findings for Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder (NCT NCT04502589)

Last Updated: 2022-10-07

Results Overview

Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Participants will be accessed for the full 12 week titration plus treatment period. However, for the purposes of the study, the percent of days the participant was abstinent will be calculated and reported only for the 8 week active treatment period.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

End of treatment, up to 12 weeks

Results posted on

2022-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	Perampanel by Itself Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
Overall Study STARTED	2	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Perampanel by Itself Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
Overall Study Physician Decision	1	0

Baseline Characteristics

Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: End of treatment, up to 12 weeks

Outcome measures

Outcome measures
Measure	Perampanel by Itself n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
Percent Abstinent Days	3.13 Percentage of days Interval 0.0 to 6.25	100 Percentage of days Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Baseline to end of treatment, up to 12 weeks

Alcohol craving will be assessed using the Alcohol Urge Questionnaire (AUG). The AUG is an 8-item survey asking participants to rate their craving for alcohol on a 1 to 7 scale. The answers are summed yielding a score ranging from 7 to 56 with higher scores indicated higher alcohol craving.

Outcome measures

Outcome measures
Measure	Perampanel by Itself n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
Change in Alcohol Craving	4 score on a scale Interval 2.0 to 6.0	-1 score on a scale Interval -2.0 to 0.0

SECONDARY outcome

Timeframe: End of treatment, Up to 8 weeks

Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Based on participant report, the percent of days the participant drank heavily will be calculated over the 8 week active treatment period.

Outcome measures

Outcome measures
Measure	Perampanel by Itself n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
Percent Heavy Drinking Days	73.60 percentage of days Interval 65.6 to 81.6	0 percentage of days Interval 0.0 to 0.0

Adverse Events

Perampanel by Itself

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Perapanel With Disulfiram

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Perampanel by Itself n=2 participants at risk Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram n=2 participants at risk Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
General disorders Vehicle accident	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.

Other adverse events

Additional Information

Albert Arias, M.D.

Virginia Commonwealth University

Phone: (804) 828-5793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Perampanel by Itself n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram n=2 Participants Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily	Total n=4 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
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

Measure	Perampanel by Itself n=2 participants at risk Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups	Perapanel With Disulfiram n=2 participants at risk Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily
General disorders Weakness	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Aggression/Anger	100.0% 2/2 • Number of events 3 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Agitation	100.0% 2/2 • Number of events 3 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Anxiety	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Breathing Diffuculties	50.0% 1/2 • Number of events 3 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Confusion/Slow Thinking	100.0% 2/2 • Number of events 4 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Nervous system disorders Decreased Coordination	50.0% 1/2 • Number of events 3 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Depressed Mood	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Ear and labyrinth disorders Dizziness	50.0% 1/2 • Number of events 3 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Eye disorders Double Vision	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Drowsiness	100.0% 2/2 • Number of events 5 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Gastrointestinal disorders Dry Mouth	100.0% 2/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Fatigue	100.0% 2/2 • Number of events 5 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	100.0% 2/2 • Number of events 4 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Hostility	100.0% 2/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	100.0% 2/2 • Number of events 4 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Cardiac disorders Irregular Heartbeat	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Irritability	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Skin and subcutaneous tissue disorders Itching	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Lightheadedness	50.0% 1/2 • Number of events 4 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Gastrointestinal disorders Loss of Appetite	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Loss of Balance	50.0% 1/2 • Number of events 3 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Gastrointestinal disorders Nausea/Vomiting	100.0% 2/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Panic Attacks	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Restlessness	100.0% 2/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Shortness of Breath	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	0.00% 0/2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Psychiatric disorders Speech Problems	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Nervous system disorders Trouble Speaking or Swallowing	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
General disorders Unsteady Walking	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	50.0% 1/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
Nervous system disorders Unusual Skin Sensations	50.0% 1/2 • Number of events 1 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.	100.0% 2/2 • Number of events 2 • At baseline and weekly for eight weeks The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.