Clinical trial NCT01876719: AR08 for Treatment of ADHD in Children
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ADHD
Keywords: ADHD
AR08
adrenergic receptor agonists
randomized, placebo-controlled clinical trial
Lead sponsor: Arbor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 122
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ADHD-RS-IV
timeFrame: Day 35
Secondary outcomes:
measure: CGI-ADHD-S/I
timeFrame: Day 35
measure: Conners' Parent Rating Scale
timeFrame: Day 49
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 49
Other outcomes:
Locations:
city: Brandenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: St. Charles
country: United States
facility: Midwest Research Group at St. Charles Psychiatric Associates
state: Missouri
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Houston
country: United States
facility: Bayou City Research Ltd.
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials
state: Texas
city: Herndon
country: United States
facility: Neuroscience Associates
state: Virginia
Study officials:
affiliation: Arbor Pharmaceuticals
name: Laurence Downey, MD
role: STUDY_DIRECTOR
References: