AR08 for Treatment of ADHD in Children

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01876719

Enrollment

122

Registered

2013-06-13

Start date

2013-06-30

Completion date

2015-02-28

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, AR08, adrenergic receptor agonists, randomized, placebo-controlled clinical trial

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.

Interventions

DRUGAR08

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
CGI-ADHD-S/I	Day 35	CGI-ADHD-S (severity) and I (improvement) - change from Baseline.
Conners' Parent Rating Scale	Day 49	Conners' Parent Rating Scale (CPRS-R-S) will be assessed through Day 49.
Columbia Suicide Severity Rating Scale (C-SSRS)	Day 49	Columbia Suicide Severity Rating Scale (C-SSRS) - incident rate will be assessed through Day 49.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026