NCT01876719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

June 11, 2013

Last Update Submit

November 10, 2015

Conditions

ADHD

Keywords

ADHDAR08adrenergic receptor agonistsrandomized, placebo-controlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • ADHD-RS-IV

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

    Day 35

Secondary Outcomes (3)

  • CGI-ADHD-S/I

    Day 35

  • Conners' Parent Rating Scale

    Day 49

  • Columbia Suicide Severity Rating Scale (C-SSRS)

    Day 49

Study Arms (4)

0.5 mg AR08

EXPERIMENTAL

0.5 mg AR08, QD for 7 weeks

Drug: AR08

1.0 mg AR08

EXPERIMENTAL

1.0 mg AR08, QD for 7 weeks

Drug: AR08

2.0 mg AR08

EXPERIMENTAL

2.0 mg AR08, QD for 7 weeks

Drug: AR08

Placebo

PLACEBO COMPARATOR

Placebo, QD for 7 weeks

Drug: Placebo

Interventions

AR08DRUG
0.5 mg AR081.0 mg AR082.0 mg AR08
PlaceboDRUG
Placebo

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Florida Clinical Research Center, LLC

Brandenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

CNS Healthcare

Orlando, Florida, 32806, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Janus Center for Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Midwest Research Group at St. Charles Psychiatric Associates

Saint Charles, Missouri, 63304, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Bayou City Research Ltd.

Houston, Texas, 77007, United States

Location

Houston Clinical Trials

Houston, Texas, 77098, United States

Location

Neuroscience Associates

Herndon, Virginia, 20170, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Laurence Downey, MD

    Arbor Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 13, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2014

Study Completion

February 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-11

Locations

US(13)