Status:
COMPLETED
Open-Label, Extension Study to 810P202
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Impulsive Aggression Comorbid With ADHD in Children
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggressi...
Eligibility Criteria
Inclusion
- Successful completion of the 810P202 study.
- Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
- Weight of at least 20kg.
- Able and willing to swallow tablets whole and not chewed, cut or crushed.
- Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.
Exclusion
- Body Mass Index (BMI) in 97th percentile or above.
- Clinically significant change in health status that, in the opinion of 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).
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01416064
Start Date
September 1 2011
End Date
February 1 2013
Last Update
May 2 2017
Active Locations (28)
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1
Dothan, Alabama, United States
2
Los Angeles, California, United States
3
Santa Ana, California, United States
4
Wildomar, California, United States