- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02691182
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
October 19, 2020 updated by: Supernus Pharmaceuticals, Inc.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
491
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Orlando, Florida, United States, 32801
- CNS Healthcare of Orlando
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open-label treatment with SPN-810
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
36 months
|
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
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Assessed at baseline, at the 2-month visit, every 6 months during the study, and at the end of study visit
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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
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Assessed at baseline, every 3 months during the study, and at the end of study visit
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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
|
36 months
|
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
|
36 months
|
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
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
February 2, 2016
First Submitted That Met QC Criteria
February 19, 2016
First Posted (Estimate)
February 25, 2016
Study Record Updates
Last Update Posted (Actual)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 810P304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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