AR08 for Treatment of ADHD in Children

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Placebo; Drug: AR08

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Brandenton, Florida, United States, 34201
      • Florida Clinical Research Center, LLC
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • Orlando, Florida, United States, 32806
      • CNS Healthcare
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33407
      • Janus Center For Psychiatric Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
  • Missouri
    • St. Charles, Missouri, United States, 63304
      • Midwest Research Group at St. Charles Psychiatric Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • CNS Healthcare
  • Texas
    • Houston, Texas, United States, 77098
      • Houston Clinical Trials
    • Houston, Texas, United States, 77007
      • Bayou City Research Ltd.
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Neuroscience Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 mg AR08; 0.5 mg AR08, QD for 7 weeks	Drug: AR08
Experimental: 1.0 mg AR08; 1.0 mg AR08, QD for 7 weeks	Drug: AR08
Experimental: 2.0 mg AR08; 2.0 mg AR08, QD for 7 weeks	Drug: AR08
Placebo Comparator: Placebo; Placebo, QD for 7 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD-RS-IV	The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).	Day 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI-ADHD-S/I	CGI-ADHD-S (severity) and I (improvement) - change from Baseline.	Day 35
Conners' Parent Rating Scale	Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49.	Day 49
Columbia Suicide Severity Rating Scale (C-SSRS)	Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49.	Day 49

Collaborators and Investigators

• Sponsor: Arbor Pharmaceuticals, Inc.
• Investigators: Study Director: Laurence Downey, MD, Arbor Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: ADHD; AR08; adrenergic receptor agonists; randomized, placebo-controlled clinical trial
• Other Study ID Numbers: AR08.001