Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Information source: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder (ADHD)
Intervention: AR11 (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Arbor Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Laurence Downey, MD, Study Director, Affiliation: Arbor Pharmaceuticals, LLC.
Summary
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in
approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will
enroll in the study to take open-label AR11 twice daily and undergo dose optimization
activities for 8 weeks. Patients who achieve a stable dose during the dose optimization
period will continue participation and will be randomized to take double-blind medication
(AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind
treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom
setting utilizing SKAMP and PERMP assessments. At the end of the second double blind
treatment period, patients will be evaluated for ADHD symptoms in a second laboratory
classroom setting utilizing SKAMP and PERMP assessments.
Clinical Details
Official title: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of AR11 (Amphetamine Sulfate) in Pediatric Patients (Ages 6-12) With Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: SKAMP-Combined scores
Secondary outcome: SKAMP-Combined scoresSKAMP-Attention and -Deportment scores PERM-P scores
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female between 6 and 12 years of age, inclusive, at the time of Screening.
2. Diagnosed as meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for ADHD.
3. A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or
greater.
4. An ADHD Rating Scale (ADHD-RS) score at Screening and Baseline greater than or equal
to the 90th percentile normative values for gender and age in at least one of the
following categories: hyperactive-impulsive subscale, inattentive subscale, or total
score.
Exclusion Criteria:
1. Secondary or co-morbid diagnoses other than ADHD, with the exception of simple
phobias, oppositional defiant disorder, elimination disorders, motor skills
disorders, communication disorders, learning disorders, adjustment disorders, and
sleep disorders if, in the opinion of the investigator, the associated symptoms do
not confound assessment of safety or efficacy.
2. Clinically significant cognitive impairment as assessed in the clinical judgment of
the Investigator.
3. History of any of the following medical disorders: seizure disorder (excluding a
history of febrile seizures), structural cardiac disorders, serious cardiac
conditions, hypertension, untreated thyroid disease, glaucoma, Tourette's disorder,
or chronic tics.
4. Clinically significant abnormal ECG finding or abnormal cardiac finding on physical
exam (including presence of a pathologic murmur) at Screening.
5. Use of any psychotropic medication (sedative hypnotics prescribed as a sleep aid at a
stable dose for at least 30 days prior to Baseline, at bedtime only, are allowed
during the study).
6. A history of hypersensitivity or intolerance to any formulation of amphetamine or
lisdexamfetamine.
Locations and Contacts
Florida Clinical Research Center, LLC., Bradenton, Florida 34201, United States
Florida Clinical Research Center, LLC, Maitland, Florida 32751, United States
Miami Research Associates, South Miami, Florida 33143, United States
Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada 89128, United States
Duke University Medical Center, Durham, North Carolina 27705, United States
Bayou City Research Ltd., Houston, Texas 77007, United States
Westex Clinical Investigations, Houston, Texas 79423, United States
Additional Information
Starting date: December 2013
Last updated: June 11, 2014
|