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

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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)

Key facts

Study ID: NCT03659929
Run by: Arbor Pharmaceuticals, Inc.
People needed: 320
Starts: 2018-09-18
Expected to finish: 2019-04-12
Last updated by the study team: 2024-09-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is male or female between 18 and 55 years of age, inclusive, at the time of Screening.
Meets criteria for diagnosis of ADHD using Conners' Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV™) adapted for DSM-5™ (CAADID), including onset of ADHD symptoms before the age of 12.
Has an AISRS total score of ≥26 at Visit 2.
Has a clinician-administered Clinical Global Impression-Severity (CGI-S) score of 4 or greater at Visit 2.
In the clinical judgment of the Investigator, the subject needs pharmacological treatment for ADHD.
Must read and write English at a level sufficient to provide written informed consent and to complete study-related materials.
For subjects currently on a stable dose of allowed non-ADHD medication, there will be no expected changes in subject's medications during the study with the exception of medications listed in Section 5.9.2.
Males and females who are fertile and sexually active with a partner of the opposite sex must adhere to contraception requirements for the duration of the study as follows:
Females of childbearing potential must agree to be abstinent or to use highly effective forms of contraception.
Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months do not require contraception during the study.
Males , with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception from screening through the end of study.

You may not qualify if…

Has a primary psychiatric diagnosis other than ADHD.
Has any other current secondary or co-morbid medical, psychiatric, or social condition which, in the opinion of the investigator, might compromise subject safety, or is likely to interfere with protocol compliance or to confound the assessment of safety or efficacy.
Has a history or current symptoms of bipolar disorder, schizophrenia, or psychotic disorder.
Has clinically significant cognitive impairment in the clinical judgment of the Investigator.
Has a Body Mass Index (BMI) of <17 or ≥39 kg/m2.
Has a Screening or Baseline triplicate-average blood pressure of ≥139 millimeter of mercury (mmHg) systolic or ≥89 mmHg diastolic. Blood pressure will be taken in triplicate, and the average will be used for evaluating entry criteria.
Is pregnant or breastfeeding, or is planning to become pregnant during the study.
Has a history of any of the following disorders:
Seizure disorder (excluding a history of isolated febrile seizures <6 years old),
Inadequately or not treated hypertension is defined as a subject who has blood pressure indicative of Stage 2 hypertension (systolic pressure ≥140 mmHg or diastolic pressure ≥90 mmHg). Subjects who are adequately treated must be on a stable dose of antihypertensive medications for 3 months prior to screening and their antihypertensive medications are not anticipated to change.
Untreated thyroid disease. Subjects with a history of thyroid disease who have been on a stable dose of thyroid hormone for at least three months are eligible to participate if their thyroid-stimulating hormone (TSH) does not fall in the excluded range, shown below in 14.
Glaucoma
Tourette's disorder, or chronic tics.
Subjects who have had gastrointestinal surgery or a procedure that involves:
Excision or partial excision of the esophagus, stomach, small and large intestine, liver, pancreas or biliary tree. Appendectomy, cholecystectomy and/or removal of gallstones in the bile ducts (as long as the ducts remain intact) are exceptions.
Reduction of the stomach volume without excision or partial excision of the stomach (e.g. restrictive surgery/procedure)
Obesity treatments that can affect gastrointestinal (GI) capacity or function, such as electrical stimulation systems, gastric balloon systems, and gastric external drainage systems
Has Electrocardiogram (ECG) or clinical evidence of the following:
Fridericia's corrected QT wave interval (QTcF) > 470 milliseconds (msec) for females, and > 450 msec for males
Atrial or ventricular hypertrophy
Intraventricular conduction defects other than incomplete right bundle branch block in the absence of other heart disease
Myocardial infarct, ischemia, or symptomatic coronary artery disease within 1 year prior to the Screening Visit
Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly normal sinus rhythm
Second or third degree atrioventricular block
Heart failure

Where it is running

114: Pharmacology Research Institute — Encino, California, United States
133: Collaborative Neuroscience Network — Garden Grove, California, United States
124: Pharmacology Research Institute — Newport Beach, California, United States
121: CT Clinical Research Associates — Cromwell, Connecticut, United States
108: Meridien Research — Bradenton, Florida, United States
103: Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
129: Sarkis Clinical Trials — Gainesville, Florida, United States
105: Meridien Research — Lakeland, Florida, United States
120: Meridien Research — Maitland, Florida, United States
130: Medical Research Group of Central Florida — Orange City, Florida, United States
123: APG Research, LLC — Orlando, Florida, United States
115: Clinical Neuroscience Solutions (CNS), Inc. — Orlando, Florida, United States
104: Northwest Behavioral Research Center — Marietta, Georgia, United States
131: Advanced Clinical Research, Inc. — Meridian, Idaho, United States
113: Capstone Clinical Research — Libertyville, Illinois, United States
134: Rochester Center for Behavioral Medicine — Rochester Hills, Michigan, United States
128: Clinical Neurophysiology Services — Sterling, Michigan, United States
107: Center for Psychiatry and Behavioral Medicine — Las Vegas, Nevada, United States
116: Alliance - Hassman Research Institute — Berlin, New Jersey, United States
127: Center for Emotional Fitness — Cherry Hill, New Jersey, United States
101: Princeton Medical Institute — Princeton, New Jersey, United States
118: Bioscience Research, LLC — Mount Kisco, New York, United States
119: Neurobehavioral Clinical Research, Inc. — Canton, Ohio, United States
106: Summit Research Network — Portland, Oregon, United States
126: Coastal Carolina Research — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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