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COMPLETEDPhase 2NCT01876719

AR08 for Treatment of ADHD in Children

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...

Lead sponsor: Arbor Pharmaceuticals, Inc.•13 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Arbor Pharmaceuticals, Inc.

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 9, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment122

Start dateJun 2013

Last updatedDec 9, 2015

Condition

Locations shown

Florida Clinical Research Center, LLC

Brandenton, Florida

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida

Segal Institute for Clinical Research

North Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2015Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions