CompletedPhase 2

Open-Label, Extension Study to 810P202

United States78 participantsStarted 2011-09

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

Who can participate

Age range6 Years – 12 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD

Timeframe: over 6 months

Trial details

NCT IDNCT01416064

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

View on ClinicalTrials.gov More Impulsive Aggression Comorbid With ADHD in Children trials