Attention Deficit Hyperactivity DisorderPhase 3NCT03597503
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
A Phase 3 study testing SPN-810 in people with Attention Deficit Hyperactivity Disorder, run by Supernus Pharmaceuticals, Inc. at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- SPN-810
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 38 sitesUnited States
- Study dates
- 31 Jul 2018to 22 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Texas Physicians Medical Research Group
Arlington, Texas, 76014
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
BioBehavioral Research of Austin P.C.
Austin, Texas, 78759
Hugo W Moser Research Institute at Kennedy Krieger
Baltimore, Maryland, 21205
Gaolin Research, LLC
Beaumont, Texas, 77702
Hassmann Research Institute
Berlin, New Jersey, 08009
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219
Ericksen Research & Development
Clinton, Utah, 84015
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
Ohio State University Nisonger Center Clinical Trials Program
Columbus, Ohio, 43210
ProScience
Culver City, California, 90230
Relaro Medical Trials
Dallas, Texas, 75243
iResearch Atlanta
Decatur, Georgia, 30030
InSite Clinical Research
DeSoto, Texas, 75115
Houston Clinical Trials
Houston, Texas, 08009
Dicovery MM Services Inc. Houston
Houston, Texas, 77061
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32217
Meridien Research aka Florida Clinical Research Center, LLC
Lakeland, Florida, 33805
FMCScience
Lampasas, Texas, 76550
Capstone Clinical Research
Libertyville, Illinois, 60048
Alivation Research, LLC
Lincoln, Nebraska, 68526
Florida Clinical Research Center, LLC.
Maitland, Florida, 32751
CNS Healthcare
Memphis, Tennessee, 38119
Miami Clinical Research
Miami, Florida, 33155
Discovery MM Service, Inc. Missouri
Missouri City, Texas, 77459
AMR Conventions Research
Naperville, Illinois, 60563
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118
Neuropsychiatric Research Center of Orange County
Orange, California, 92868
Aspen Clinical Research
Orem, Utah, 84058
Psychiatric Associates
Overland Park, Kansas, 66211
Finger Lakes Clinical Research
Rochester, New York, 14618
St. Charles Psychiatric Associates Midwest Research Center
Saint Charles, Missouri, 63304
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33143
University of South Florida- Dept. of Psychiatry and Neurosciences
Tampa, Florida, 33613
Family Psychiatry of the Woodlands
The Woodlands, Texas, 77381
Children's National Medical Center/Children's Research Institute
Washington D.C., District of Columbia, 20310
About this study
Official title: Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
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.
Read the 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.
.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- SPN-810, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPN-810Drug
Flexible dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Flexible dose of SPN-810 | Experimental | Subjects treated with flexible dose of SPN-810 Receives: Drug: SPN-810 |
| Placebo | Placebo comparator | Subjects treated with Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start31 Jul 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Why it stopped: Business decision, not related to safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597503
- Sponsor's protocol ID
- 810P503
- Status last verified
- Apr 2024
- First submitted
- 12 Jul 2018
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
- ClinicalTrials.gov ID
- NCT03597503
- Acronym / sponsor ID
- 810P503
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision, not related to safety
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
| Arm | Type | Receives |
|---|---|---|
| Flexible dose of SPN-810 | Experimental | Drug: SPN-810Subjects treated with flexible dose of SPN-810 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects treated with Placebo |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPN-810Flexible dose | Drug | Flexible dose of SPN-810 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary
Time frame: 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.
3 secondary outcomes
Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)
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)
Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score
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).
Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate
Time frame: Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPN-810 in people with Attention Deficit Hyperactivity Disorder, run by Supernus Pharmaceuticals, Inc. at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary (time frame: Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.