Clinical trial NCT01416064: Open-Label, Extension Study to 810P202
Official title: Open-Label Extension Study to Evaluate the Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impulsive Aggression Comorbid With ADHD in Children
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Successful completion of the 810P202 study.
2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
3. Weight of at least 20kg.
4. Able and willing to swallow tablets whole and not chewed, cut or crushed.
5. 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:

1. Body Mass Index (BMI) in 97th percentile or above.
2. 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.
3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Assess the efficacy of 810M
timeFrame: over 6 months
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Washington, D.C.
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Libertyville
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Owensboro
country: United States
state: Kentucky
city: Toms River
country: United States
state: New Jersey
city: Stony Brook
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Bellevue
country: United States
state: Washington
city: Bothell
country: United States
state: Washington
Study officials:
References: