AR08 for Treatment of ADHD in Children

ADHD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876719
• Other study ID #: AR08.001
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2013
• Last updated: November 10, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: Arbor Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• AR08

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-RS-IV	The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).	Day 35	No
Secondary	CGI-ADHD-S/I	CGI-ADHD-S (severity) and I (improvement) - change from Baseline.	Day 35	No
Secondary	Conners' Parent Rating Scale	Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49.	Day 49	No
Secondary	Columbia Suicide Severity Rating Scale (C-SSRS)	Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49.	Day 49	Yes