Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2013-06-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.5 mg AR08
0.5 mg AR08, QD for 7 weeks
AR08
1.0 mg AR08
1.0 mg AR08, QD for 7 weeks
AR08
2.0 mg AR08
2.0 mg AR08, QD for 7 weeks
AR08
Placebo
Placebo, QD for 7 weeks
Placebo
Interventions
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AR08
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
17 Years
ALL
No
Sponsors
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Arbor Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Laurence Downey, MD
Role: STUDY_DIRECTOR
Arbor Pharmaceuticals
Locations
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Florida Clinical Research Center, LLC
Brandenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 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
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Midwest Research Group at St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
CNS Healthcare
Memphis, Tennessee, United States
Bayou City Research Ltd.
Houston, Texas, United States
Houston Clinical Trials
Houston, Texas, United States
Neuroscience Associates
Herndon, Virginia, United States
Countries
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Other Identifiers
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AR08.001
Identifier Type: -
Identifier Source: org_study_id