Phase 3
N=320
Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03659929 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms — -11.1; -18.2; -18.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amphetamine Sulfate (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arbor Pharmaceuticals, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms |
-11.1; -18.2; -18.1 | — |
| SECONDARY Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores |
-5.2; -8.3; -8.0; -5.9; -9.9; -10.0 | — |
| SECONDARY Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline |
-0.5; -0.9; -1.0; -0.7; -1.1; -1.3 | — |
| SECONDARY Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline |
3.3; 2.9; 2.8; 3.2; 2.6; 2.4 | — |
| SECONDARY Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline |
-7.4; -13.6; -14.6; -6.4; -11.5; -12.8 | — |
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)
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 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
- Functionally significant cardiac structural abnormality or valvular disease
- Cardiomyopathy
- Any other cardiovascular condition that the Investigator feels may predispose the subject to cardiovascular events (e.g. myocardial infarction, stroke) or arrhythmia
- Known family history of sudden cardiac death in the absence of pre-existing heart disease.
- Use of any psychotropic medication within 28 days of the Baseline visit except for ADHD medication. (Sedative hypnotics prescribed as a sleep aid at a stable dose for at least 28 days prior to Baseline, at bedtime only, are allowed during the study.)
- Has used prohibited drugs or agents within 28 days of the Baseline visit through Study Visit 7. (Stimulant medications are allowed until 7 days before the Baseline visit.) Non-stimulant ADHD medications (guanfacine, bupropion, clonidine, and/or atomoxetine) are not allowed within 28 days of Visit 2 or at any time during the study. Note: Medications that are being taken for psychiatric or medical disorders other than ADHD should not be discontinued for the purpose of qualifying for study participation unless the medication is deemed medically unnecessary by the prescribing physician.
- Has received an investigational drug with
Data sourced from ClinicalTrials.gov (NCT03659929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.