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

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ClinicalTrials.gov Identifier: NCT01986062
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : April 19, 2016
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Arbor Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 11, 2013
First Posted Date  ICMJE November 18, 2013
Results First Submitted Date  ICMJE June 5, 2015
Results First Posted Date  ICMJE April 19, 2016
Last Update Posted Date July 21, 2020
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
SKAMP-Combined Scores [ Time Frame: 2 hours post-dose ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
SKAMP-Combined Scores [ Time Frame: Two hours post-dose ]
Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • SKAMP-Combined Scores [ Time Frame: 0.75, 4, 6, 8, 10 hours post-dose ]
    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.
  • SKAMP Subscale - Attention Scores [ Time Frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose ]
    The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24.
  • SKAMP Subscale - Deportment Scores [ Time Frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose ]
    The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24.
  • PERM-P Scores - Number of Problems Attempted [ Time Frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose ]
    Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).
  • PERM-P Scores - Number of Problems Correct [ Time Frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose ]
    Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • SKAMP-Combined scores [ Time Frame: 0.75, 4, 6, 8, and 10 hours post-dose ]
  • SKAMP-Attention and -Deportment scores [ Time Frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose ]
  • PERM-P scores [ Time Frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose ]
    Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE
  • Drug: AR11
    Other Name: amphetamine sulfate
  • Drug: Placebo
    Other Name: matching Placebo
Study Arms  ICMJE
  • Experimental: AR11 (amphetamine sulfate) (1 week) - double blind
    AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
    Intervention: Drug: AR11
  • Placebo Comparator: Placebo (1 week) - double blind
    Placebo, administered orally, BID, for one week (crossover to AR11 administration week 2)
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2014)
97
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2013)
100
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986062
Other Study ID Numbers  ICMJE AR11.001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arbor Pharmaceuticals, Inc.
Study Sponsor  ICMJE Arbor Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Laurence Downey, MD Arbor Pharmaceuticals, LLC.
PRS Account Arbor Pharmaceuticals, Inc.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP