Impulsive Aggression Comorbid With ADHDPhase 2NCT01364662
A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing SPN-810 in people with Impulsive Aggression Comorbid With ADHD, run by Supernus Pharmaceuticals, Inc. at 27 sites in United States.
Trial summary
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Impulsive Aggression Comorbid With ADHD
- What is being tested?
- SPN-810
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 27 sitesUnited States
- Study dates
- Jun 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy pediatric male or female subjects, age 6 to 12 years.
- Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
- R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
- IQ greater than 71.
- Weight of >=20kg
- current treatment with psychostimulant (1 month prior to screening)
Who cannot join
None listed.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Atlanta, Georgia
Study site
Bellevue, Washington
Study site
Bothell, Washington
Study site
Bradenton, Florida
Study site
Charleston, South Carolina
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dothan, Alabama
Study site
Gainesville, Florida
Study site
Hialeah, Florida
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Libertyville, Illinois
Study site
Los Angeles, California
Study site
Maitland, Florida
Study site
Memphis, Tennessee
Study site
North Miami, Florida
Study site
Orlando, Florida
Study site
Owensboro, Kentucky
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Santa Ana, California
Study site
Stony Brook, New York
Study site
Tampa, Florida
Study site
Terre Haute, Indiana
Study site
Toms River, New Jersey
Study site
Washington D.C., District of Columbia
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
- Conditions
- Impulsive Aggression Comorbid With ADHD
- Being tested
- SPN-810, Placebo
- Keywords
- Impulsive Aggression, Attention Deficit Hyperactivity Disorder, ADHD
- 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
administered orally
PlaceboDrug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: SPN-810 |
| 3 | Experimental | Not described Receives: Drug: SPN-810 |
| 4 | Experimental | Not described Receives: Drug: SPN-810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in aggressive behavior as assessed by R-MOAS score
Measured: Change from baseline to Visit 10
Secondary outcomes (4)
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Measured: Visit 2 to End of Study
Change in CGI-S
Measured: Baseline to Visit 5
CGI-I score at each post-baseline Visit
Measured: Baseline to Visit 5
Change in SNAP-IV ADHD scores
Measured: Baseline to Visit 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulsive Aggression Comorbid With ADHDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 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
- NCT01364662
- Sponsor's protocol ID
- 810P202
- Status last verified
- Nov 2015
- First submitted
- 25 May 2011
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01364662
- Acronym / sponsor ID
- 810P202
- Conditions
- Impulsive Aggression Comorbid With ADHD
- Keywords
- Impulsive Aggression, Attention Deficit Hyperactivity Disorder, ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Placebo |
| 2 | Experimental | Drug: SPN-810 |
| 3 | Experimental | Drug: SPN-810 |
| 4 | Experimental | Drug: SPN-810 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy pediatric male or female subjects, age 6 to 12 years.
- Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
- R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
- IQ greater than 71.
- Weight of >=20kg
Key exclusion criteria (0 listed)
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-810administered orally | Drug | 2, 3, 4 |
| Placeboadministered orally | Drug | 1 |
Primary outcome
Reduction in aggressive behavior as assessed by R-MOAS score
Time frame: Change from baseline to Visit 10
4 secondary outcomes
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Time frame: Visit 2 to End of Study
Change in CGI-S
Time frame: Baseline to Visit 5
CGI-I score at each post-baseline Visit
Time frame: Baseline to Visit 5
Change in SNAP-IV ADHD scores
Time frame: Baseline to Visit 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPN-810 in people with Impulsive Aggression Comorbid With ADHD, run by Supernus Pharmaceuticals, Inc. at 27 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 6 inclusion and 0 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: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in aggressive behavior as assessed by R-MOAS score (time frame: Change from baseline to Visit 10). 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 11 Feb 2021.