AR08 for Treatment of ADHD in Children

Arbor Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: ADHD

Treatments: Drug: Placebo; Drug: AR08

Study type: Interventional

Funder types: Industry

Identifiers

NCT01876719

AR08.001

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 4 patient groups, including a placebo group

0.5 mg AR08

Experimental group

Description:

0.5 mg AR08, QD for 7 weeks

Treatment:

Drug: AR08

1.0 mg AR08

Experimental group

Description:

1.0 mg AR08, QD for 7 weeks

Treatment:

Drug: AR08

2.0 mg AR08

Experimental group

Description:

2.0 mg AR08, QD for 7 weeks

Treatment:

Drug: AR08

Placebo

Placebo Comparator group

Description:

Placebo, QD for 7 weeks

Treatment:

Drug: Placebo