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OpenTrials
Completed

NCT Number: NCT01876719

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 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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Clinical Research Center, LLC, Brandenton, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

AR08

Drug

Placebo

Drug

Primary outcomes

  1. ADHD-RS-IV

    Time frame: Day 35

    The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).

Secondary outcomes

  1. CGI-ADHD-S/I

    Time frame: Day 35

    CGI-ADHD-S (severity) and I (improvement) - change from Baseline.

  2. Conners' Parent Rating Scale

    Time frame: Day 49

    Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49.

  3. Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Day 49

    Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49.

Sponsors and collaborators

Lead sponsor

Arbor Pharmaceuticals, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 13, 2013
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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