Trial · NCT03597503
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
NCT03597503, Phase 3, Terminated, Supernus Pharmaceuticals, Inc.; results first posted 2024-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment. Trials, record NCT03597503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03597503
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
- NCT number
- NCT03597503
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- SPN-810, Placebo
- First posted
- 2018-07-24
- Last updated
- 2024-04-24
- Results first posted
- 2024-02-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | percent change in IA behaviors | MEAN |
| SECONDARY | 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) | 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. | score on a scale | MEAN |
| SECONDARY | 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). | 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. | units on a scale | MEAN |
| SECONDARY | 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) | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary | Placebo | -31.73 | Standard Deviation 25.510 | percent change in IA behaviors | |
| Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary | Flexible Dose of SPN-810 | -35.66 | Standard Deviation 77.422 | percent change in IA behaviors | |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 4 | -0.5 | Standard Deviation 0.77 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Flexible Dose of SPN-810 | Visit 4 | -0.6 | Standard Deviation 0.69 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 5 | -0.7 | Standard Deviation 0.73 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Flexible Dose of SPN-810 | Visit 5 | -1.1 | Standard Deviation 0.94 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 6 | -1.1 | Standard Deviation 0.96 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Flexible Dose of SPN-810 | Visit 6 | -1.2 | Standard Deviation 0.90 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Placebo | Visit 7 | -1.3 | Standard Deviation 1.03 | score on a scale |
| Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Flexible Dose of SPN-810 | Visit 7 | -1.4 | Standard Deviation 1.00 | score on a scale |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | STARTED | Flexible Dose of SPN-810 | 21 | |
| Overall Study | Treated | Placebo | 20 | |
| Overall Study | Treated | Flexible Dose of SPN-810 | 21 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | Flexible Dose of SPN-810 | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Flexible Dose of SPN-810 | 4 |
Source ClinicalTrials.gov
Adverse 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 | 2 | 20 | |
| other | Headache | Nervous system disorders | Flexible Dose of SPN-810 | 2 | 21 | |
| other | Somnolence | Nervous system disorders | Placebo | 2 | 20 | |
| other | Somnolence | Nervous system disorders | Flexible Dose of SPN-810 | 0 | 21 | |
| other | Dystonia | Nervous system disorders | Placebo | 1 | 20 | |
| other | Dystonia | Nervous system disorders | Flexible Dose of SPN-810 | 0 | 21 | |
| other | Lethargy | Nervous system disorders | Placebo | 1 | 20 | |
| other | Lethargy | Nervous system disorders | Flexible Dose of SPN-810 | 0 | 21 | |
| other | Parkinsonism | Nervous system disorders | Placebo | 1 | 20 | |
| other | Parkinsonism | Nervous system disorders | Flexible Dose of SPN-810 | 0 | 21 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, all-cause mortality | Flexible Dose of SPN-810 | 0 | 21 |
| Total, other adverse events | Placebo | 8 | 20 |
| Total, other adverse events | Flexible Dose of SPN-810 | 4 | 21 |
| Total, serious adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Flexible Dose of SPN-810 | 0 | 21 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flexible Dose of SPN-810 vs Placebo: deaths from any cause | Trial comparisons |
| Flexible Dose of SPN-810 vs Placebo: serious adverse events | Trial comparisons |
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/NCT03597503
GET https://conductscience.org/api/trials/v1/NCT03597503/results?page=2