Back to resultsTreatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPN-810
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301or 810P302 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor.
- Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
- Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302.
- Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants).
- Weight of at least 20 kg.
- Written Informed Consent obtained from the subject's parent or LAR, and written Informed Assent obtained from the subject if appropriate.
Exclusion Criteria:
- Body Mass Index (BMI) in 99th percentile or above.
- Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study.
- Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).
- Current substance or alcohol use.
- Suicidal thoughts or behaviors confirmed at last visit in the previous double-blind randomized study.
Sites / Locations
- CNS Healthcare of Orlando
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label treatment with SPN-810
Arm Description
Subjects aged 6-12 years will be treated with SPN-810 starting day 1 of Visit 1 of the study. The subjects will be given a choice of extending their participation in the study every 6-month period for up to 36 months. The clinician will be able to adjust the dose of SPN-810 throughout the study based on subject's response and tolerability.
Outcomes
Primary Outcome Measures
Adverse Events will be summarized at the subject and event level. Treatment Emergent Adverse Events (TEAEs) will be summarized by severity and relationship. TEAE incidence table will be listed and summarized by group of optimized doses.
Clinical laboratory values will be summarized by descriptive statistics for hematology and chemistry. For quantitative laboratory parameters both actual values and change from baseline will be summarized.
ECG results will be summarized by visit and by group of optimized doses using descriptive statistics. Tabular summaries of quantitative ECG parameters will be presented.
Vital Signs will be summarized by group of optimized doses using descriptive statistics. Both actual values and change from baseline will be presented.
Suicidal ideation and behavior will be assessed through Columbia Suicide Severity Rating Scale outcomes. The summary will be presented by group of optimized doses.
The occurrence of neurological side effects will be assessed by change in score from baseline to each of the post-baseline visit for Simpson Angus Scale, Barnes-Akathesia Scale and Abnormal Involuntary Movement Scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT02691182
First Posted
February 2, 2016
Last Updated
October 19, 2020
Sponsor
Supernus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02691182
Brief Title
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in this study. This is a Phase 3 open label extension (OLE) study with the objective of collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given a choice to extend participation in this study every 6 months for up to 36 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label treatment with SPN-810
Arm Type
Experimental
Arm Description
Subjects aged 6-12 years will be treated with SPN-810 starting day 1 of Visit 1 of the study. The subjects will be given a choice of extending their participation in the study every 6-month period for up to 36 months. The clinician will be able to adjust the dose of SPN-810 throughout the study based on subject's response and tolerability.
Intervention Type
Drug
Intervention Name(s)
SPN-810
Primary Outcome Measure Information:
Title
Adverse Events will be summarized at the subject and event level. Treatment Emergent Adverse Events (TEAEs) will be summarized by severity and relationship. TEAE incidence table will be listed and summarized by group of optimized doses.
Time Frame
36 months
Title
Clinical laboratory values will be summarized by descriptive statistics for hematology and chemistry. For quantitative laboratory parameters both actual values and change from baseline will be summarized.
Time Frame
Assessed at baseline, at the 2-month visit, every 6 months during the study, and at the end of study visit
Title
ECG results will be summarized by visit and by group of optimized doses using descriptive statistics. Tabular summaries of quantitative ECG parameters will be presented.
Time Frame
Assessed at baseline, every 3 months during the study, and at the end of study visit
Title
Vital Signs will be summarized by group of optimized doses using descriptive statistics. Both actual values and change from baseline will be presented.
Time Frame
36 months
Title
Suicidal ideation and behavior will be assessed through Columbia Suicide Severity Rating Scale outcomes. The summary will be presented by group of optimized doses.
Time Frame
36 months
Title
The occurrence of neurological side effects will be assessed by change in score from baseline to each of the post-baseline visit for Simpson Angus Scale, Barnes-Akathesia Scale and Abnormal Involuntary Movement Scale.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301or 810P302 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor.
Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302.
Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants).
Weight of at least 20 kg.
Written Informed Consent obtained from the subject's parent or LAR, and written Informed Assent obtained from the subject if appropriate.
Exclusion Criteria:
Body Mass Index (BMI) in 99th percentile or above.
Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study.
Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).
Current substance or alcohol use.
Suicidal thoughts or behaviors confirmed at last visit in the previous double-blind randomized study.
Facility Information:
Facility Name
CNS Healthcare of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
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