Trial · NCT02691182
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
NCT02691182, Phase 3, Terminated, Supernus Pharmaceuticals, Inc.; results first posted 2024-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4). Trials, record NCT02691182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02691182
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
- NCT number
- NCT02691182
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 491 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- SPN-810
- First posted
- 2016-02-25
- Last updated
- 2024-05-16
- Results first posted
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24). | 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. The data represent the total score change from baseline at each visit for the duration of the study, a total of 60 months. The baseline score represents the total score at the last visit of each double-blind study. |
| Primary | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24). | 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 from baseline to each visit during the study. The baseline score represents the total score at the last visit of each double-blind study. |
| Primary | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24). | The Clinical Global Impression - Improvement Scale (CGI-I) is a clinician's assessment of how much the IA behaviors have improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=Very much improved, 2= Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Data represent the score at each visit during the study. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24). | Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study. | score on a scale | MEAN |
| PRIMARY | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24). | Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study. | score on a scale | MEAN |
| PRIMARY | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24). | Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group444
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | <18 mg SPN-810 | VE Score Month 3 | -7.1 | Standard Deviation 5.18 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 18 mg to < 24 mg SPN-810 | VE Score Month 3 | -6.8 | Standard Deviation 5.57 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 24 mg to < 36 mg SPN-810 | VE Score Month 3 | -5.5 | Standard Deviation 5.41 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 36 mg to ≤54 mg SPN-810 | VE Score Month 3 | -6.4 | Standard Deviation 5.84 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | <18 mg SPN-810 | PH Score Month 3 | -23.7 | Standard Deviation 17.41 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 18 mg to < 24 mg SPN-810 | PH Score Month 3 | -18.5 | Standard Deviation 21.57 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 24 mg to < 36 mg SPN-810 | PH Score Month 3 | -13.5 | Standard Deviation 17.28 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 36 mg to ≤54 mg SPN-810 | PH Score Month 3 | -16.9 | Standard Deviation 17.78 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | <18 mg SPN-810 | PR Score Month 3 | -16.1 | Standard Deviation 11.47 | score on a scale |
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 18 mg to < 24 mg SPN-810 | PR Score Month 3 | -13.6 | Standard Deviation 13.48 | score on a scale |
1 to 10 of 444Source ClinicalTrials.gov
See all 444 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | <18 mg SPN-810 | 38 | |
| Overall Study | STARTED | 18 mg to < 24 mg SPN-810 | 159 | |
| Overall Study | STARTED | 24 mg to < 36 mg SPN-810 | 131 | |
| Overall Study | STARTED | 36 mg to ≤54 mg SPN-810 | 163 | |
| Overall Study | COMPLETED | <18 mg SPN-810 | 0 | |
| Overall Study | COMPLETED | 18 mg to < 24 mg SPN-810 | 1 | |
| Overall Study | COMPLETED | 24 mg to < 36 mg SPN-810 | 2 | |
| Overall Study | COMPLETED | 36 mg to ≤54 mg SPN-810 | 1 | |
| Overall Study | NOT COMPLETED | <18 mg SPN-810 | 38 | |
| Overall Study | NOT COMPLETED | 18 mg to < 24 mg SPN-810 | 158 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | <18 mg SPN-810 | 1 | 38 | 1 |
| other | Nasopharyngitis | Infections and infestations | 18 mg to < 24 mg SPN-810 | 10 | 159 | 10 |
| other | Nasopharyngitis | Infections and infestations | 24 mg to < 36 mg SPN-810 | 11 | 131 | 13 |
| other | Nasopharyngitis | Infections and infestations | 36 mg to ≤54 mg SPN-810 | 11 | 163 | 14 |
| other | Upper respiratory tract infection | Infections and infestations | <18 mg SPN-810 | 0 | 38 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | 18 mg to < 24 mg SPN-810 | 14 | 159 | 17 |
| other | Upper respiratory tract infection | Infections and infestations | 24 mg to < 36 mg SPN-810 | 7 | 131 | 13 |
| other | Upper respiratory tract infection | Infections and infestations | 36 mg to ≤54 mg SPN-810 | 12 | 163 | 15 |
| other | Influenza | Infections and infestations | <18 mg SPN-810 | 2 | 38 | 3 |
| other | Influenza | Infections and infestations | 18 mg to < 24 mg SPN-810 | 5 | 159 | 5 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | <18 mg SPN-810 | 0 | 38 |
| Total, all-cause mortality | 18 mg to < 24 mg SPN-810 | 0 | 159 |
| Total, all-cause mortality | 24 mg to < 36 mg SPN-810 | 0 | 131 |
| Total, all-cause mortality | 36 mg to ≤54 mg SPN-810 | 0 | 163 |
| Total, other adverse events | <18 mg SPN-810 | 18 | 38 |
| Total, other adverse events | 18 mg to < 24 mg SPN-810 | 56 | 159 |
| Total, other adverse events | 24 mg to < 36 mg SPN-810 | 56 | 131 |
| Total, other adverse events | 36 mg to ≤54 mg SPN-810 | 66 | 163 |
| Total, serious adverse events | <18 mg SPN-810 | 3 | 38 |
| Total, serious adverse events | 18 mg to < 24 mg SPN-810 | 5 | 159 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02691182
GET https://conductscience.org/api/trials/v1/NCT02691182/results?page=2