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

Miami Research Associates

6141 Sunset Dr # 301
South Miami, Florida 33143

(305) 598-3125