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

NCT00626236 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 810P201
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Conduct Disorder; Attention Deficit Disorder With Hyperactivity

Keywords

ADHD and conduct problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Changes From Baseline in the CGI-S

  Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

• Clinical Global Impression - Improvement Scale (CGI-I)

  Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

• SNAP-IV ADHD Inattention

  Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

• SNAP-IV Subscales ADHD Hyperactivity/Impulsivity

  Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

• SNAP-IV Subscales - ADHD Combined

  Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Study Arms (4)

Treatment 1

EXPERIMENTAL

Treatment 1: SPN-810 5mg/day for subjects \<30kg and 10mg/day for subjects ≥30kg

Drug: SPN-810

Treatment 2

EXPERIMENTAL

Treatment 2: SPN-810 10mg/day for subjects \<30kg and 20mg/day for subjects ≥30kg.

Drug: SPN-810

Treatment 3

EXPERIMENTAL

Treatment 3: SPN-810 15mg/day for subjects \<30kg and 30mg/day for subjects ≥30kg.

Drug: SPN-810

Treatment 4

EXPERIMENTAL

Treatment 4: SPN-810 20mg/day for subjects \<30kg and 40mg/day for subjects ≥30kg.

Drug: SPN-810

Interventions

SPN-810 DRUG

1.67mg capsule taken TID

Also known as: molindone

Treatment 1

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy pediatric male or female subjects, age 6 to 12 years.
• Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
• 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.
• IQ greater than 71.

You may not qualify if:

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

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (9)

Florida Clinical Research Center

Bradenton, Florida, 32408, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

CNS Healthcare

Orlando, Florida, 32806, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

The Psychopharm Research Cntr - LSU Dept of Psychiatry

Shreveport, Louisiana, 71103, United States

Location

IPS Research

Oklahoma City, Oklahoma, 73103, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Alliance Research Group

Richmond, Virginia, 23229, United States

Location

Northwest Clinical Trials

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• 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.

  PMID: 22372512 DERIVED

Related Links

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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Conduct Disorder

Interventions

Molindone

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gianpiera Ceresoli-Borroni Director Clinical Research
• Organization: Supernus Pharmaceuticals

gceresoliborroni@supernus.com

3018382521

Study Officials

• Robert Findling, MD

  University Hospitals Case Medical Center/Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: October 21, 2008
• Primary Completion: September 23, 2009
• Study Completion: September 23, 2009
• Last Updated: December 9, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Locations

US (9)