AR08 for Treatment of ADHD in Children

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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ADHD

Intervention / Treatment
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* Drug: AR08
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 mg AR08<br>0.5 mg AR08, QD for 7 weeks | Drug: AR08<br> <br> |
| Experimental: 1.0 mg AR08<br>1.0 mg AR08, QD for 7 weeks | Drug: AR08<br> <br> |
| Experimental: 2.0 mg AR08<br>2.0 mg AR08, QD for 7 weeks | Drug: AR08<br> <br> |
| Placebo Comparator: Placebo<br>Placebo, QD for 7 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, AR08, adrenergic receptor agonists, randomized, placebo-controlled clinical trial