NCT03659929

Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate

A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the AR19.004 study is to assess the efficacy of AR19 compared to placebo using the Adult ADHD Investigator Symptom Rating Scale (AISRS)

Detailed description

This is a randomized, fixed-dose, double-blind, multicenter trial to investigate the safety and efficacy of AR19 in the treatment of ADHD in adults from 18 through 55 years of age. Safety parameters and therapeutic effect will be evaluated throughout the trial. A target of 312 subjects is set for enrollment. Once subjects are determined to meet all inclusion criteria and were screened, they will be randomized to 20 or 40 mg AR19 daily or placebo.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Amphetamine Sulfate	active experimental AR19
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-04-12
• Completion: 2019-04-12
• First posted: 2018-09-06
• Last updated: 2024-09-03
• Results posted: 2024-09-03

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study