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Open-Label, Extension Study to 810P202

Information source: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Impulsive Aggression Comorbid With ADHD in Children

Intervention: Molindone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Supernus Pharmaceuticals, Inc.

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).

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Assess the efficacy of 810M

Eligibility

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Dothan, Alabama, United States

Los Angeles, California, United States

Santa Ana, California, United States

Wildomar, California, United States

Washington, District of Columbia, United States

Bradenton, Florida, United States

Gainesville, Florida, United States

Hialeah, Florida, United States

Jacksonville, Florida, United States

Maitland, Florida, United States

North Miami, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Libertyville, Illinois, United States

Indianapolis, Indiana, United States

Terre Haute, Indiana, United States

Owensboro, Kentucky, United States

Toms River, New Jersey, United States

Stony Brook, New York, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Bellevue, Washington, United States

Bothell, Washington, United States

Additional Information

Starting date: September 2011
Last updated: May 22, 2013

Page last updated: August 23, 2015

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