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

NCT00626236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-12-09

Study results available
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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

  • Attention Deficit Disorder With Hyperactivity
  • Conduct Disorder

Interventions

DRUG

SPN-810

5mg capsule taken TID

DRUG

SPN-810

6.67 mg capsule taken TID

DRUG

SPN-810

1.67mg capsule taken TID

DRUG

SPN-810

3.33mg capsule taken TID

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Findling, MD · University Hospitals Case Medical Center/Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-21
Primary Completion
2009-09-23
Completion
2009-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626236 on ClinicalTrials.gov