Open-Label, Extension Study to 810P202

Completed · Phase 2

Conditions studied: Impulsive Aggression Comorbid With ADHD in Children

In brief

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 Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).

Key facts

Study ID

NCT01416064

Run by

Supernus Pharmaceuticals, Inc.

People needed

78

Starts

2011-09-01

Expected to finish

2013-02-01

Last updated by the study team

2017-05-02

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Ana, California, United States
• Study site — Wildomar, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Libertyville, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Terre Haute, Indiana, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Toms River, New Jersey, United States
• Study site — Stony Brook, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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