Overview

This trial is active, not recruiting.

Condition adhd
Treatment ar08
Phase phase 2
Sponsor Arbor Pharmaceuticals, Inc.
Start date June 2013
End date September 2014
Trial size 120 participants
Trial identifier NCT01876719, AR08.001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
0.5 mg AR08, QD for 7 weeks
ar08
(Experimental)
1.0 mg AR08, QD for 7 weeks
ar08
(Experimental)
2.0 mg AR08, QD for 7 weeks
ar08
(Placebo Comparator)
Placebo, QD for 7 weeks

Primary Outcomes

Measure
ADHD-RS-IV
time frame: Day 35

Secondary Outcomes

Measure
CGI-ADHD-S/I
time frame: Day 35
Conners' Parent Rating Scale
time frame: Day 49
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Day 49

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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.

Additional Information

Official 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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Arbor Pharmaceuticals, Inc..