Status:
COMPLETED
AR08 for Treatment of ADHD in Children
Lead Sponsor:
Arbor Pharmaceuticals, Inc.
Conditions:
ADHD
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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 twent...
Eligibility Criteria
Inclusion
- Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator
- Minimum score of 28 on the ADHD-RS-IV at Baseline
- Male or female ages 6 - 17 years, inclusive, at the time of Screening
- Weighs ≥21 kg (46 pounds).
- Is functioning at age appropriate levels intellectually, as deemed by the Investigator.
Exclusion
- Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview).
- 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)
- History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening
- Current usage of medications known to cause QTc prolongation or ADHD medications.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01876719
Start Date
June 1 2013
End Date
February 1 2015
Last Update
December 9 2015
Active Locations (13)
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1
Florida Clinical Research Center, LLC
Brandenton, Florida, United States, 34201
2
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
3
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
4
CNS Healthcare
Orlando, Florida, United States, 32806