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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
active experimental AR19
Matching placebo
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.
Time frame: Week 5 (Visit 7)
Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores
Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale (summed). The total score is the sum of the inattentive and hyperactive-impulsive subscales. Higher values represent more severe hyperactivity and/or inattentiveness.
Time frame: Up to 5 weeks
Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline
CGI-Severity (CGI-S): The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Time frame: Up to 5 weeks
Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline
"Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."
Time frame: Up to 5 weeks
Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline
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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
...and 21 more locations
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning (GEC) and 9 non-overlapping scales among 2 summary index scales (Metacognition Index \[MI\] and Behavioral Regulation Index \[BRI\]) that assess aspects of executive function and problems with self-regulation from the perspective of the individual. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 70 items yields the GEC raw score (range: 70-210), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score ≥ 65 is considered abnormally elevated). The post-baseline GEC T-score is converted to a change from baseline T-score. A lower change from baseline GEC T-score (\<0) represents a better outcome.
Time frame: Up to 5 weeks