Clinical trial NCT01986062: Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
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 ADHD in a Laboratory Classroom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
AR11
classroom design
amphetamine sulfate
Lead sponsor: Arbor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 97
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 to take open-label AR11 BID 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 each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: SKAMP-Combined Scores
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: SKAMP-Combined Scores
timeFrame: 0.75, 4, 6, 8, 10 hours post-dose
measure: SKAMP Subscale - Attention Scores
timeFrame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
measure: SKAMP Subscale - Deportment Scores
timeFrame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
measure: PERM-P Scores - Number of Problems Attempted
timeFrame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
measure: PERM-P Scores - Number of Problems Correct
timeFrame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: Bayou City Research Ltd.
state: Texas
city: Houston
country: United States
facility: Westex Clinical Investigations
state: Texas
Study officials:
affiliation: Arbor Pharmaceuticals, LLC.
name: Laurence Downey, MD
role: STUDY_DIRECTOR
References:
citation: Childress AC, Brams M, Cutler AJ, Kollins SH, Northcutt J, Padilla A, Turnbow JM. The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):402-14. doi: 10.1089/cap.2014.0176. Epub 2015 Feb 18.
citation: Childress AC, Newcorn JH, Cutler AJ. Gender Effects in the Efficacy of Racemic Amphetamine Sulfate in Children with Attention-Deficit/Hyperactivity Disorder. Adv Ther. 2019 Jun;36(6):1370-1387. doi: 10.1007/s12325-019-00942-5. Epub 2019 Apr 10.