AR08 for Treatment of ADHD in Children

Completed · Phase 2 · Has a placebo group

Conditions studied: ADHD

In brief

This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.

Key facts

Study ID

NCT01876719

Run by

Arbor Pharmaceuticals, Inc.

People needed

122

Starts

2013-06-01

Expected to finish

2015-02-01

Last updated by the study team

2015-12-09

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator
• Minimum score of 28 on the ADHD-RS-IV at Baseline
• Male or female ages 6 - 17 years, inclusive, at the time of Screening
• Weighs ≥21 kg (46 pounds).
• Is functioning at age appropriate levels intellectually, as deemed by the Investigator.

You may not qualify if…

• Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview).
• Has a positive response to either question 4 or 5 of the Baseline /Screening version of the pediatric Columbia Suicide Severity Rating Scale (C-SSRS)
• History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening
• Current usage of medications known to cause QTc prolongation or ADHD medications.

Where it is running

• Florida Clinical Research Center, LLC — Brandenton, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• CNS Healthcare — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Janus Center for Psychiatric Research — West Palm Beach, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Midwest Research Group at St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• CNS Healthcare — Memphis, Tennessee, United States
• Bayou City Research Ltd. — Houston, Texas, United States
• Houston Clinical Trials — Houston, Texas, United States
• Neuroscience Associates — Herndon, Virginia, United States

Full record on ClinicalTrials.gov

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