AR08 for Treatment of ADHD in Children

Phase 2

Completed

• Conditions: ADHD
• Interventions: Drug: Placebo; Drug: AR08

• Registration Number: NCT01876719
• Lead Sponsor: Arbor Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-13
• Primary Completion: 2014-10
• Study Completion: 2015-02
• Disposition First Submitted: 2015-06-05
• Disposition First Submitted QC: 2015-06-05
• Disposition First Posted: 2015-07-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, QD for 7 weeks
0.5 mg AR08	AR08	0.5 mg AR08, QD for 7 weeks
1.0 mg AR08	AR08	1.0 mg AR08, QD for 7 weeks
2.0 mg AR08	AR08	2.0 mg AR08, QD for 7 weeks

Primary Outcome Measures

Name	Time	Method
ADHD-RS-IV	Day 35	The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Janus Center for Psychiatric Research; 🇺🇸 West Palm Beach, Florida, United States

Houston Clinical Trials; 🇺🇸 Houston, Texas, United States

Florida Clinical Research Center, LLC; 🇺🇸 Brandenton, Florida, United States

Segal Institute for Clinical Research; 🇺🇸 North Miami, Florida, United States

CNS Healthcare; 🇺🇸 Memphis, Tennessee, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

Neuroscience Associates; 🇺🇸 Herndon, Virginia, United States

Midwest Research Group at St. Charles Psychiatric Associates; 🇺🇸 St. Charles, Missouri, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

Center for Psychiatry and Behavioral Medicine, Inc.; 🇺🇸 Las Vegas, Nevada, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Jacksonville, Florida, United States

Bayou City Research Ltd.; 🇺🇸 Houston, Texas, United States