Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
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ClinicalTrials.gov Identifier: NCT02618434 |
Recruitment Status :
Completed
First Posted : December 1, 2015
Last Update Posted : November 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Attention Deficit Hyperactivity Disorder (ADHD) | Drug: SPN-810 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 297 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | November 2019 |
Actual Study Completion Date : | November 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Low dose SPN-810
Subjects will be treated with low dose of SPN-810
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Drug: SPN-810 |
Experimental: High dose SPN-810
Subjects will be treated with high dose of SPN-810
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Drug: SPN-810 |
Placebo Comparator: Placebo
Subjects will be treated with a Placebo
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Drug: Placebo |
- Frequency of impulsive aggression behaviors per 7 days over a period of 7 weeks. [ Time Frame: 7 weeks ]The frequency of impulsive aggression behaviors will be assessed using an impulsive aggression diary, a newly developed and validated electronic observer reported outcome measurement tool.

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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
- Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.
Exclusion Criteria:
- Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
- Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
- Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618434

Responsible Party: | Supernus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02618434 |
Other Study ID Numbers: |
810P302 |
First Posted: | December 1, 2015 Key Record Dates |
Last Update Posted: | November 29, 2019 |
Last Verified: | November 2019 |
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |