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

Phase 3 Completed 320 enrolled Arbor Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

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)

Timeline

Start: 2018-09-18
Primary completion: 2019-04-12
Completion: 2019-04-12

Outcome

Met primary endpoint

paper The least squares mean treatment differences versus placebo (97.5% CI) were -7.2 (-11.3 to -3.1) for the AR19 20-mg group PMID 34428356 ↗

paper each P < .001). PMID 34428356 ↗

paper Conclusions: AR19 demonstrated efficacy on all endpoints PMID 34428356 ↗

Publications

Faraone SV, Childress A, Caras S, Arnold VK, Montano CB, Sarkis EH, Cutler AJ, Young JL. A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AR19, a Manipulation-Resistant Formulation of Amphetamine Sulfate, in Adults With Attention-Deficit/Hyperactivity Disorder. J Clin Psychiatry. 2021 Aug 24;82(5):21m13927. doi: 10.4088/JCP.21m13927.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphetamine	Unknown	20 mg	—
Subject	Amphetamine	Unknown	40 mg	—