AR08 for Treatment of ADHD in Children

Status:	Completed
Conditions:	Psychiatric, ADHD
Therapuetic Areas:	Psychiatry / Psychology, Other
Healthy:	No
Age Range:	6 - 17
Updated:	4/21/2016
Start Date:	June 2013
End Date:	February 2015

A Randomized, Double-Blind, Placebo-Controlled, Forced Titration, Proof-of-Concept Study of AR08 in the Treatment of Attention Deficit Hyperactivity Disorder in Children (Ages 6 - 17)

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.

Inclusion Criteria:

1. Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical
interview, MINI-KID, as assessed by the Investigator

2. Minimum score of 28 on the ADHD-RS-IV at Baseline

3. Male or female ages 6 - 17 years, inclusive, at the time of Screening

4. Weighs ≥21 kg (46 pounds).

5. Is functioning at age appropriate levels intellectually, as deemed by the
Investigator.

Exclusion Criteria:

1. Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be
established by the MINI-KID interview).

2. 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)

3. History of daily usage (at least 28 days/month) of either anti-hypertensive or
prophylactic anti-migraine medications prior to Screening

4. Current usage of medications known to cause QTc prolongation or ADHD medications.

We found this trial at

sites

Janus Center for Psychiatric Research

5601 Corporate Way
West Palm Beach, Florida 33407

561-238-3036