Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
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|ClinicalTrials.gov Identifier: NCT03597503|
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: SPN-810 Drug: Placebo||Phase 3|
This study is an addition to the ongoing 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 will be administered in patients diagnosed with ADHD and associated feature of IA, who are currently being treated with an FDA-approved standard ADHD treatment and with persistent IA behaviors. The frequency of impulsive aggressive behaviors will be assessed as a primary outcome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||July 29, 2020|
|Estimated Study Completion Date :||December 20, 2021|
Experimental: Flexible dose of SPN-810
Subjects will be treated with flexible dose of SPN-810
Placebo Comparator: Placebo
Subjects will be treated with 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 measured using an impulsive aggression (IA) diary, developed by the sponsor as an electronic observer-reported outcome (eObsRO) instrument.
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): NCT03597503
|Contact: Ronald Marcus, MDfirstname.lastname@example.org|
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