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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01364662
First received: May 25, 2011
Last updated: May 22, 2013
Last verified: May 2013

May 25, 2011
May 22, 2013
June 2011
October 2012   (final data collection date for primary outcome measure)
Reduction in aggressive behavior as assessed by R-MOAS score [ Time Frame: after approximately 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01364662 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: after approximately 6 weeks ] [ Designated as safety issue: Yes ]
Safety as assessed by safety scales, AEs, clinical labs, vitals, PEs, ECGs, etc
Same as current
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Impulsive Aggression Comorbid With ADHD
  • Drug: Molindone
    administered orally twice daily
  • Drug: Placebo
    administered orally twice daily
  • Experimental: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: Molindone
  • Experimental: 3
    Intervention: Drug: Molindone
  • Experimental: 4
    Intervention: Drug: Molindone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
October 2012
October 2012   (final data collection date for primary outcome measure)

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)
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01364662
810P202
No
Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc.
Not Provided
Not Provided
Supernus Pharmaceuticals, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP