Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting

NCT01986062 | Completed Phase 4 Results

• 1 other identifier: AR11.001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 7

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD; AR11; classroom design; amphetamine sulfate

Outcome Measures

Primary Outcomes (1)

• SKAMP-Combined Scores

  Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale \[SKAMP\]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.

  2 hours post-dose

Secondary Outcomes (5)

• SKAMP-Combined Scores

  0.75, 4, 6, 8, 10 hours post-dose

• SKAMP Subscale - Attention Scores

  0.75, 2, 4, 6, 8, and 10 hours post-dose

• SKAMP Subscale - Deportment Scores

  0.75, 2, 4, 6, 8, and 10 hours post-dose

• PERM-P Scores - Number of Problems Attempted

  0.75, 2, 4, 6, 8, and 10 hours post-dose

• PERM-P Scores - Number of Problems Correct

  0.75, 2, 4, 6, 8, and 10 hours post-dose

Study Arms (2)

AR11 (amphetamine sulfate) (1 week) - double blind

EXPERIMENTAL

AR11, administered orally, BID, for one week (crossover to placebo administration week 2)

Drug: AR11

Placebo (1 week) - double blind

PLACEBO COMPARATOR

Placebo, administered orally, BID, for one week (crossover to AR11 administration week 2)

Drug: Placebo

Interventions

AR11 DRUG

Also known as: amphetamine sulfate

AR11 (amphetamine sulfate) (1 week) - double blind

Placebo DRUG

Also known as: matching Placebo

Placebo (1 week) - double blind

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female between 6 and 12 years of age, inclusive, at the time of Screening.
• Diagnosed as meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for ADHD.
• A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater.
• 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.

You may not qualify if:

• 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.
• Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator.
• 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.
• Clinically significant abnormal ECG finding or abnormal cardiac finding on physical exam (including presence of a pathologic murmur) at Screening.
• 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).
• A history of hypersensitivity or intolerance to any formulation of amphetamine or lisdexamfetamine.

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (7)

Florida Clinical Research Center, LLC.

Bradenton, Florida, 34201, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Bayou City Research Ltd.

Houston, Texas, 77007, United States

Location

Westex Clinical Investigations

Houston, Texas, 79423, United States

Location

Related Publications (2)

• 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.

  PMID: 25692608 BACKGROUND

• 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.

  PMID: 30972657 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: Dr. Steve Caras
• Organization: Arbor Pharmaceuticals

scaras@arborpharma.com

(470) 235-2327

Study Officials

• Laurence Downey, MD

  Arbor Pharmaceuticals, LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 21, 2020
• Results First Posted: April 19, 2016

Record last verified: 2016-03

Locations

US (7)