Not provided
Not provided
Not provided
Not provided
Not provided
Business decision, not related to safety
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexible dose of SPN-810 | Experimental | Subjects treated with flexible dose of SPN-810 |
|
| Placebo | Placebo Comparator | Subjects treated with Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPN-810 | Drug | Flexible dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProScience | Culver City | California | 90230 | United States | ||
| Neuropsychiatric Research Center of Orange County |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects treated with Placebo |
| FG001 | Flexible Dose of SPN-810 | Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day). |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2018 | Dec 28, 2023 |
Not provided
Not provided
Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36) |
| 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). | From Baseline/Visit 3 (Day 1) to 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 | 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). | Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36) |
| Orange |
| California |
| 92868 |
| United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Children's National Medical Center/Children's Research Institute | Washington D.C. | District of Columbia | 20310 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32217 | United States |
| Meridien Research aka Florida Clinical Research Center, LLC | Lakeland | Florida | 33805 | United States |
| Florida Clinical Research Center, LLC. | Maitland | Florida | 32751 | United States |
| Miami Clinical Research | Miami | Florida | 33155 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| University of South Florida- Dept. of Psychiatry and Neurosciences | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| AMR Conventions Research | Naperville | Illinois | 60563 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Hugo W Moser Research Institute at Kennedy Krieger | Baltimore | Maryland | 21205 | United States |
| St. Charles Psychiatric Associates Midwest Research Center | Saint Charles | Missouri | 63304 | United States |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | United States |
| Hassmann Research Institute | Berlin | New Jersey | 08009 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| University of Cincinnati Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 | United States |
| Ohio State University Nisonger Center Clinical Trials Program | Columbus | Ohio | 43210 | United States |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| Paradigm Research Professionals | Oklahoma City | Oklahoma | 73118 | United States |
| CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Texas Physicians Medical Research Group | Arlington | Texas | 76014 | United States |
| BioBehavioral Research of Austin P.C. | Austin | Texas | 78759 | United States |
| Gaolin Research, LLC | Beaumont | Texas | 77702 | United States |
| Relaro Medical Trials | Dallas | Texas | 75243 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Houston Clinical Trials | Houston | Texas | 08009 | United States |
| Dicovery MM Services Inc. Houston | Houston | Texas | 77061 | United States |
| FMCScience | Lampasas | Texas | 76550 | United States |
| Discovery MM Service, Inc. Missouri | Missouri City | Texas | 77459 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | United States |
| Ericksen Research & Development | Clinton | Utah | 84015 | United States |
| Aspen Clinical Research | Orem | Utah | 84058 | United States |
|
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Participants is based on the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects treated with Placebo |
| BG001 | Flexible Dose of SPN-810 | Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percent change in IA behaviors | Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks |
|
|
| ||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36) |
|
| |||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36). |
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | percentage of participants | Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36) |
|
|
Baseline/Visit 3 (Day 1) to Visit 8 (Day 46)-End of Study, a total of 46 days
Adverse events reporting pertains to the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects treated with Placebo | 0 | 20 | 0 | 20 | 8 | 20 |
| EG001 | Flexible Dose of SPN-810 | Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day) | 0 | 21 | 0 | 21 | 4 | 21 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianpiera Ceresoli-Borroni/ Director Clinical Development | Supernus | 3018382521 | gceresoliborroni@supernus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2023 | Dec 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|