Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

A Randomized, Multicenter, Parallel Group, Dose-Ranging Study to Evaluate the Safety and Tolerability of SPN-810 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems

The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.

Study Overview

• Status: Completed
• Conditions: Conduct Disorder; Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: SPN-810; Drug: SPN-810; Drug: SPN-810; Drug: SPN-810

Detailed Description

This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 32408
      • Florida Clinical Research Center
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Orlando, Florida, United States, 32806
      • CNS Healthcare
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • The Psychopharm Research Cntr - LSU Dept of Psychiatry
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Alliance Research Group
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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. NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people.
4. IQ greater than 71.

Exclusion Criteria:

1. Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.
2. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.
3. Any other anxiety disorder as primary diagnosis.
4. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.
5. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1; Treatment 1: SPN-810 5mg/day for subjects <30kg and 10mg/day for subjects ≥30kg	Drug: SPN-810; 1.67mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 3.33mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 5mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 6.67 mg capsule taken TID; Other Names: molindone
Experimental: Treatment 2; Treatment 2: SPN-810 10mg/day for subjects <30kg and 20mg/day for subjects ≥30kg.	Drug: SPN-810; 1.67mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 3.33mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 5mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 6.67 mg capsule taken TID; Other Names: molindone
Experimental: Treatment 3; Treatment 3: SPN-810 15mg/day for subjects <30kg and 30mg/day for subjects ≥30kg.	Drug: SPN-810; 1.67mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 3.33mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 5mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 6.67 mg capsule taken TID; Other Names: molindone
Experimental: Treatment 4; Treatment 4: SPN-810 20mg/day for subjects <30kg and 40mg/day for subjects ≥30kg.	Drug: SPN-810; 1.67mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 3.33mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 5mg capsule taken TID; Other Names: molindone; Drug: SPN-810; 6.67 mg capsule taken TID; Other Names: molindone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score	The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).	Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Changes From Baseline in the CGI-S	The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after the administration of study medication. The severity of illness (CGI-S) is rated by the investigator on a 7-point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy.	Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Clinical Global Impression - Improvement Scale (CGI-I)	Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline on a 7-point scale with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).	Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV ADHD Inattention	The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #0-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the inattention subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.	Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity	The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the Hyperactivity/Impulsivity subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.	Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales - ADHD Combined	The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the combined subscale, the scores range from 0-54, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.	Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Robert Findling, MD, University Hospitals Case Medical Center/Case Western Reserve University

Publications and helpful links

General Publications

• Stocks JD, Taneja BK, Baroldi P, Findling RL. A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems. J Child Adolesc Psychopharmacol. 2012 Apr;22(2):102-11. doi: 10.1089/cap.2011.0087. Epub 2012 Feb 28.

Helpful Links

• A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2008
• Primary Completion (Actual): September 23, 2009
• Study Completion (Actual): September 23, 2009

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: February 28, 2008
• First Posted (Estimated): February 29, 2008

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: ADHD and conduct problems
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Molindone
• Other Study ID Numbers: 810P201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No