Trial · NCT02618434
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
NCT02618434, Phase 3, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2024-03-18
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 2). Trials, record NCT02618434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02618434
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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 2)
- NCT number
- NCT02618434
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 297 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- SPN-810 (18 mg), SPN-810 (36 mg), Placebo
- First posted
- 2015-12-01
- Last updated
- 2024-03-18
- Results first posted
- 2024-03-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary | Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) 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 6, 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 | Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | Baseline/Visit 3 (Day 1), Visit 4 (Week 1), Visit 5 (Week 2), and Visit 6 (Week 5). The total duration of the study was 5 weeks. | 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 three time points: Visit 4 (Week 1); Visit 5 (Week 2) and Visit 6 (Week 5). |
| Secondary | Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated | Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks | The Clinical Global Impression - Improvement Scale (CGI-I) is an assessment of how much the patient's illness has 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 |
| Secondary | Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28) | Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks. | The CHQ-PF28 is a short generic measure of health status and health-related quality of life. The 28 items have 4, 5, or 6 response options, divided over 8 multi-item scales (physical functioning, general behavior, mental health, self-esteem, general health perceptions, parental impact: emotional, parental impact: time, and family activities) and 5 single item concepts (role functioning: emotional/behavior, role functioning: physical, bodily pain, family cohesion, and change in health). In addition, the individual scale scores will be aggregated to derive 2 summary component scores: the physical functioning and psychosocial health summary scores. The range on subscales and the overall scale is 0-100 (0 = worst possible health state; 100 = best possible health state). Data represent the change from Baseline (Visit 3) to one time point, Visit 6 (Week 5). |
| Secondary | Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) | Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks. | The PSI-4-SF is a 36-item self-report measure of parenting stress. Three subscales Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC) consist of 12 items each. Parent chooses one of the 5 responses against each item. The 5 responses are: Strongly Agree (SA), Agree (A), Not Sure (NS), Disagree (D), and Strongly Disagree (SD) to indicate the degree to which they agree with each statement. The PD subscale raw score ranges from 12-60, P-CDI and DC each subscale raw score ranges from 16-56. The total stress raw score is the sum of the three subscales (PD+P-CDI+ DC) with a minimum score of 44 and a maximum score of 172. The total stress score is then converted into the percentile score. Parents with a 91st percentile or higher are experiencing clinically significant levels of stress. Data represents the mean change in percentile score from Baseline (Visit 3) and one time point, Visit 6 (Week 5). |
| Secondary | Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Caregiver Rated | Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks | The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subjects' global functioning prior to and after administration of a study medication. The scale was also rated by the Caregiver to assess the improvement of IA behaviors. . CGI-I was evaluated by the Caregiver 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 |
| Secondary | Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale | Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks. | The Swanson, Nolan, Pelham Rating Scale-Revised (SNAP-IV) includes 18 ADHD and 8 oppositional defiant disorder (ODD) symptoms. The symptoms are scored on a 4-point scale, not at all=0, just a little=1, Quite a bit= 2, very much=3. The ratings from the SNAP-IV scale are grouped into the following 4 subscales: ADHD Inattention (items #1-9), ADHD Hyperactivity/Impulsivity (items#10-18), ODD (items# 19-26), and ADHD-combined (first two scales combined, items #1-18). Each observed subscale score is the average rating of the items scores for the subscale where scores range from 0-3; the higher is the score, worsen is the outcome. Data represent the change of the observed scores between Baseline (Visit 3) and the end of the study, Visit 6 (Week 5). |
| Secondary | Effect of SPN-810 on Impulsive Aggression Measured by the Percentage of Responders | Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks | A Responder was defined as a subject with at least a 30% or 50% reduction in the frequency of IA behaviors per 7 days in the Treatment (Titration and Maintenance) period relative to the Baseline period per the IA Diary. Data represent the percentage of subjects with 30% and 50% reduction in IA behaviors from Baseline to end of treatment period. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary | Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | Percent Change of IA behaviors | MEDIAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | Baseline/Visit 3 (Day 1), Visit 4 (Week 1), Visit 5 (Week 2), and Visit 6 (Week 5). The total duration of the study was 5 weeks. | Intent-to-Treat (ITT) Population: The ITT population included subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry.~Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated | Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28) | Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks. | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) | Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks. | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Caregiver Rated | Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale | Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks. | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on Impulsive Aggression Measured by the Percentage of Responders | Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks | Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary | Placebo | -54.12 | Full Range -100.0 to 63.4 | Percent Change of IA behaviors | |
| Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary | High Dose SPN-810 (36 mg) | -51.64 | Full Range -100.0 to 105.3 | Percent Change of IA behaviors | |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 4 | -0.27 | Standard Deviation 0.518 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | High Dose SPN-810 (36 mg) | Visit 4 | -0.45 | Standard Deviation 0.776 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 5 | -0.67 | Standard Deviation 0.773 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | High Dose SPN-810 (36 mg) | Visit 5 | -0.96 | Standard Deviation 1.068 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 6 | -0.93 | Standard Deviation 0.997 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) | High Dose SPN-810 (36 mg) | Visit 6 | -1.06 | Standard Deviation 1.089 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated | Placebo | Visit 4 | 3.4 | Standard Deviation 0.72 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated | High Dose SPN-810 (36 mg) | Visit 4 | 3.3 | Standard Deviation 0.90 | score on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 94 | |
| Overall Study | STARTED | Low Dose SPN-810 (18 mg) | 56 | |
| Overall Study | STARTED | High Dose SPN-810 (36 mg) | 142 | |
| Overall Study | Intent-to-Treat | Placebo | 92 | |
| Overall Study | Intent-to-Treat | Low Dose SPN-810 (18 mg) | 55 | |
| Overall Study | Intent-to-Treat | High Dose SPN-810 (36 mg) | 140 | |
| Overall Study | Modified Intent-to Treat | Placebo | 90 | |
| Overall Study | Modified Intent-to Treat | Low Dose SPN-810 (18 mg) | 53 | |
| Overall Study | Modified Intent-to Treat | High Dose SPN-810 (36 mg) | 135 | |
| Overall Study | COMPLETED | Placebo | 84 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events24
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 | Headache | Nervous system disorders | Placebo | 8 | 94 | |
| other | Headache | Nervous system disorders | Low Dose SPN-810 (18 mg) | 3 | 56 | |
| other | Headache | Nervous system disorders | High Dose SPN-810 (36 mg) | 14 | 142 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 94 | |
| other | Vomiting | Gastrointestinal disorders | Low Dose SPN-810 (18 mg) | 4 | 56 | |
| other | Vomiting | Gastrointestinal disorders | High Dose SPN-810 (36 mg) | 6 | 142 | |
| other | Blood prolactin increase | Investigations | Placebo | 2 | 94 | |
| other | Blood prolactin increase | Investigations | Low Dose SPN-810 (18 mg) | 3 | 56 | |
| other | Blood prolactin increase | Investigations | High Dose SPN-810 (36 mg) | 3 | 142 | |
| serious | Post-Traumatic Stress Disorder | Psychiatric disorders | Placebo | 1 | 94 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 94 |
| Total, all-cause mortality | Low Dose SPN-810 (18 mg) | 0 | 56 |
| Total, all-cause mortality | High Dose SPN-810 (36 mg) | 0 | 142 |
| Total, other adverse events | Placebo | 13 | 94 |
| Total, other adverse events | Low Dose SPN-810 (18 mg) | 10 | 56 |
| Total, other adverse events | High Dose SPN-810 (36 mg) | 23 | 142 |
| Total, serious adverse events | Placebo | 1 | 94 |
| Total, serious adverse events | Low Dose SPN-810 (18 mg) | 0 | 56 |
| Total, serious adverse events | High Dose SPN-810 (36 mg) | 4 | 142 |
Source ClinicalTrials.gov
Papers0
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.
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