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A Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride XR Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

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

Intervention: Molindone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Supernus Pharmaceuticals, Inc.

Summary

This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in aggressive behavior as assessed by R-MOAS score

Secondary outcome: Safety

Eligibility

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

Criteria:

Inclusion Criteria: 1. Healthy pediatric male or female subjects, age 6 to 12 years.

2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR)

diagnosis of ADHD. 3. R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization 4. IQ greater than 71. 5. Weight of >=20kg 6. current treatment with psychostimulant (1 month prior to screening)

Locations and Contacts

Dothan, Alabama, United States

Los Angeles, California, United States

Santa Ana, 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: June 2011
Last updated: May 22, 2013

Page last updated: August 23, 2015

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