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

NCT03659929 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AR19.004
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 31

Brief 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)

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms

  Change from baseline in severity of Attention Deficit Hyperactivity (ADHD) symptoms, as measured by the adult ADHD Investigator Symptom Rating Scale (AISRS), with a minimum score of 0, and maximum score of 54. Higher scores indicate more severe symptoms, or a worse outcome.

  Week 5 (Visit 7)

Secondary Outcomes (4)

• Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores

  Up to 5 weeks

• Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline

  Up to 5 weeks

• Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline

  Up to 5 weeks

• Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline

  Up to 5 weeks

Study Arms (3)

Arm 1: 20 mg/day

EXPERIMENTAL

Amphetamine Sulfate

Drug: Amphetamine Sulfate

Arm 2: 40 mg/day

EXPERIMENTAL

Amphetamine Sulfate

Drug: Amphetamine Sulfate

Arm 3: Placebo

PLACEBO COMPARATOR

Placebo, no active drug

Drug: Placebo

Interventions

Amphetamine Sulfate DRUG

active experimental AR19

Also known as: AR19

Arm 1: 20 mg/day; Arm 2: 40 mg/day

Placebo DRUG

Matching placebo

Also known as: inactive drug

Arm 3: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (31)

114: Pharmacology Research Institute

Encino, California, 91316, United States

Location

133: Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

124: Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

121: CT Clinical Research Associates

Cromwell, Connecticut, 06416, United States

Location

108: Meridien Research

Bradenton, Florida, 34201, United States

Location

103: Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

129: Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

105: Meridien Research

Lakeland, Florida, 33805, United States

Location

120: Meridien Research

Maitland, Florida, 32751, United States

Location

130: Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

123: APG Research, LLC

Orlando, Florida, 32803, United States

Location

115: Clinical Neuroscience Solutions (CNS), Inc.

Orlando, Florida, 32806, United States

Location

104: Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

131: Advanced Clinical Research, Inc.

Meridian, Idaho, 86342, United States

Location

113: Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

134: Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

128: Clinical Neurophysiology Services

Sterling, Michigan, 48314, United States

Location

107: Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

116: Alliance - Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

127: Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

101: Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

118: Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

119: Neurobehavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

106: Summit Research Network

Portland, Oregon, 97210, United States

Location

126: Coastal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

102: Clinical Neuroscience Solutions (CNS), Inc.

Memphis, Tennessee, 38119, United States

Location

132: Research Strategies of Memphis

Memphis, Tennessee, 38119, United States

Location

125: Biobehavioral Research of Austin

Austin, Texas, 78759, United States

Location

110: FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

117: Houston Clinical Trials, LLC

Houston, Texas, 77005, United States

Location

109: Ericksen Research and Development

Clinton, Utah, 84405, United States

Location

Related Publications (1)

• 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.

  PMID: 34428356 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Vice President of Clinical Development
• Organization: Azurity Pharmaceuticals, Inc.

david.sequeira@azurity.com

1-800-461-7449

Study Officials

• Steven Caras, MD, PhD

  Arbor Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 6, 2018
• Study Start: September 18, 2018
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)