Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.
Detailed description
This study was an addition to the pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD. SPN-810 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome. .
Interventions
DRUGSPN-810
Flexible dose
DRUGPlacebo
Placebo
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication. * IA confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.
Exclusion criteria
* History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder. * Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder. * Known or suspected intelligence quotient (IQ) \<70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary | Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks | The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 7, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36) | The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change between Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36). |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36). | R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH)=4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is. Data represent the total score change between the Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29), and Visit 7 (Day 36). |
| Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36) | The treatment effect on the R-MOAS was assessed to capture the severity of the aggressive behaviors. The remission rate was defined as percentage of subjects with a R-MOAS total score ≤ 10. Data represent the percentage of subjects at four time points during the treatment period: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36). |
Countries
United States
Participant flow
Recruitment details
Participants underwent a 15-day baseline period (up to -Day 15), were randomized on Day 1 to receive either placebo or SPN-180, and then entered a 2- week titration phase followed by a 3-weeks maintenance phase, and then a 1-week taper phase.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects treated with Placebo | 20 |
| Flexible Dose of SPN-810 Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day). | 21 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Flexible Dose of SPN-810 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 13.2 years STANDARD_DEVIATION 1.25 | 13.1 years STANDARD_DEVIATION 1.33 | 13.1 years STANDARD_DEVIATION 1.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 28 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 23 Participants | 13 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 16 Participants | 31 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 8 / 20 | 4 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary
The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 7, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.
Time frame: Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks
Population: Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary | -31.73 percent change in IA behaviors | Standard Deviation 25.51 |
| Flexible Dose of SPN-810 | Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary | -35.66 percent change in IA behaviors | Standard Deviation 77.422 |
Secondary
Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)
The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change between Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).
Time frame: From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36)
Population: Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 4 | -0.5 score on a scale | Standard Deviation 0.77 |
| Placebo | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 5 | -0.7 score on a scale | Standard Deviation 0.73 |
| Placebo | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 6 | -1.1 score on a scale | Standard Deviation 0.96 |
| Placebo | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 7 | -1.3 score on a scale | Standard Deviation 1.03 |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 7 | -1.4 score on a scale | Standard Deviation 1 |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 4 | -0.6 score on a scale | Standard Deviation 0.69 |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 6 | -1.2 score on a scale | Standard Deviation 0.9 |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Visit 5 | -1.1 score on a scale | Standard Deviation 0.94 |
Secondary
Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate
The treatment effect on the R-MOAS was assessed to capture the severity of the aggressive behaviors. The remission rate was defined as percentage of subjects with a R-MOAS total score ≤ 10. Data represent the percentage of subjects at four time points during the treatment period: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).
Time frame: Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)
Population: Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 4 | 10.5 percentage of participants |
| Placebo | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 5 | 21.1 percentage of participants |
| Placebo | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 6 | 27.8 percentage of participants |
| Placebo | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 7 | 38.9 percentage of participants |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 7 | 58.8 percentage of participants |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 4 | 26.3 percentage of participants |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 6 | 41.2 percentage of participants |
| Flexible Dose of SPN-810 | Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate | Visit 5 | 33.3 percentage of participants |
Secondary
Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score
R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH)=4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is. Data represent the total score change between the Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29), and Visit 7 (Day 36).
Time frame: From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).
Population: Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 4 | -1.4 units on a scale | Standard Deviation 3.89 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 4 | -3.4 units on a scale | Standard Deviation 9.55 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 4 | -2.4 units on a scale | Standard Deviation 7.62 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 4 | -1.9 units on a scale | Standard Deviation 6.94 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 4 | -9.1 units on a scale | Standard Deviation 16.53 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 5 | -3.7 units on a scale | Standard Deviation 3.93 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 5 | -8.6 units on a scale | Standard Deviation 8.87 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 5 | -5.4 units on a scale | Standard Deviation 9.93 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 5 | -2.1 units on a scale | Standard Deviation 7.88 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 5 | -19.8 units on a scale | Standard Deviation 23.37 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 6 | -5.4 units on a scale | Standard Deviation 4.17 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 6 | -7.8 units on a scale | Standard Deviation 17.91 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 6 | -7.3 units on a scale | Standard Deviation 9.38 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 6 | -3.2 units on a scale | Standard Deviation 7.94 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 6 | -23.7 units on a scale | Standard Deviation 32.21 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 7 | -5.7 units on a scale | Standard Deviation 4.31 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 7 | -12.9 units on a scale | Standard Deviation 13.89 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 7 | -8.3 units on a scale | Standard Deviation 8.85 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 7 | -3.3 units on a scale | Standard Deviation 9.14 |
| Placebo | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 7 | -30.2 units on a scale | Standard Deviation 29.99 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 7 | -9.6 units on a scale | Standard Deviation 6.6 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 4 | -5.9 units on a scale | Standard Deviation 4.32 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 6 | -6.6 units on a scale | Standard Deviation 5.12 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 4 | -4.8 units on a scale | Standard Deviation 12.62 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 7 | -7.5 units on a scale | Standard Deviation 4.99 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 4 | -6.6 units on a scale | Standard Deviation 6.57 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 6 | -12.2 units on a scale | Standard Deviation 11 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 4 | -4.6 units on a scale | Standard Deviation 10.46 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 7 | -32.3 units on a scale | Standard Deviation 15.45 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 4 | -21.9 units on a scale | Standard Deviation 19.22 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 6 | -7.6 units on a scale | Standard Deviation 6.13 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Visit 5 | -7.3 units on a scale | Standard Deviation 5.03 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 7 | -11.3 units on a scale | Standard Deviation 9.51 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Visit 5 | -12.4 units on a scale | Standard Deviation 12.34 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 6 | -3.5 units on a scale | Standard Deviation 6.3 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Visit 5 | -9.1 units on a scale | Standard Deviation 8.41 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 7 | -3.9 units on a scale | Standard Deviation 6.85 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Visit 5 | -6.0 units on a scale | Standard Deviation 9.09 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 6 | -30.0 units on a scale | Standard Deviation 15.41 |
| Flexible Dose of SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Visit 5 | -34.9 units on a scale | Standard Deviation 25.76 |