CompletedNCT01986062Updated Jul 21, 2020Results posted

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

A Phase 4 interventional study of AR11 and Placebo in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Arbor Pharmaceuticals, Inc.. Completed at 7 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by Arbor Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 97
Allocation: Randomized
Ages: 6 Years to 12 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Attention Deficit Hyperactivity Disorder (ADHD)

Browse trials for

Attention Deficit Disorder with Hyperactivity 1,514

Keywords

ADHD
AR11
classroom design
amphetamine sulfate

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 97 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Arbor Pharmaceuticals, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 97 participants (actual)

Study arms

Experimental
AR11 (amphetamine sulfate) (1 week) - double blind
AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
Drug: AR11
Placebo comparator
Placebo (1 week) - double blind
Placebo, administered orally, BID, for one week (crossover to AR11 administration week 2)
Drug: Placebo

Interventions

DrugAR11
Also known as: amphetamine sulfate
DrugPlacebo
Also known as: matching Placebo

What researchers measure

Primary outcomes

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.
Time frame: 2 hours post-dose

Secondary outcomes

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.
Time frame: 0.75, 4, 6, 8, 10 hours post-dose
SKAMP Subscale - Attention Scores
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.
Time frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
SKAMP Subscale - Deportment Scores
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.
Time frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
PERM-P Scores - Number of Problems Attempted
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).
Time frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose
PERM-P Scores - Number of Problems Correct
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).
Time frame: 0.75, 2, 4, 6, 8, and 10 hours post-dose

Results

Posted Apr 19, 2016

Participant flow

Participant flow — Overall Study
Milestone	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	Placebo (1 Week) Then AR11 (1 Week) - Double Blind
Started	47	50
Completed	46	49
Not completed	1	1
Withdrew: Lost to follow-up	1	0
Withdrew: Withdrawal by subject	0	1

Outcome measures

PrimarySKAMP-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.

Time frame:: 2 hours post-dose
Reported as:: Mean · units on a scale

SKAMP-Combined Scores
units on a scale	AR11 (Amphetamine Sulfate)	Placebo
SKAMP-Combined Scores	10.0 ± 8.24	17.8 ± 1.94

Statistical analysis

AR11 (Amphetamine Sulfate) vs Placebo · Mixed Models Analysis · p = <0.0001

SecondarySKAMP-Combined Scores

Time frame:: 0.75, 4, 6, 8, 10 hours post-dose
Reported as:: Mean · units on a scale

SKAMP-Combined Scores
units on a scale	AR11 (Amphetamine Sulfate)	Placebo
0.75 hours post-dose	11.8 ± 10.56	17.3 ± 11.38
4 hours post-dose	11.6 ± 10.04	19.8 ± 11.92
6 hours post-dose	14.5 ± 10.38	20.2 ± 11.28
8 hours post-dose	16.0 ± 11.76	22.0 ± 12.33
10 hours post-dose	16.5 ± 11.08	20.8 ± 13.33

Statistical analysis

AR11 (Amphetamine Sulfate) vs Placebo · Mixed Models Analysis · p = <0.0001

SecondarySKAMP Subscale - Attention Scores

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.

Time frame:: 0.75, 2, 4, 6, 8, and 10 hours post-dose
Reported as:: Mean · units on a scale

SKAMP Subscale - Attention Scores
units on a scale	AR11 (Amphetamine Sulfate)	Placebo
0.75 hours post-dose	2.2 ± 2.64	3.4 ± 3.06
2.0 hours post-dose	1.9 ± 2.26	3.4 ± 3.1
4.0 hours post-dose	2.2 ± 2.68	4.0 ± 3.04
6.0 hours post-dose	2.3 ± 2.43	3.6 ± 2.95
8.0 hours post-dose	2.8 ± 2.8	4.1 ± 3.01
10.0 hours post-dose	3.2 ± 3.15	4.0 ± 3.59

Statistical analysis

AR11 (Amphetamine Sulfate) vs Placebo · Mixed Models Analysis · p = <0.0001

SecondarySKAMP Subscale - Deportment Scores

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.

Time frame:: 0.75, 2, 4, 6, 8, and 10 hours post-dose
Reported as:: Mean · units on a scale

SKAMP Subscale - Deportment Scores
units on a scale	AR11 (Amphetamine Sulfate)	Placebo
0.75 hours post-dose	2.1 ± 3.53	3.9 ± 4.82
2.0 hours post-dose	1.6 ± 2.79	4.0 ± 4.58
4.0 hours post-dose	2.1 ± 3.47	4.7 ± 4.86
6.0 hours post-dose	3.1 ± 4.21	4.3 ± 4.51
8.0 hours post-dose	3.5 ± 4.38	4.9 ± 4.8
10.0 hours post-dose	3.1 ± 3.72	4.9 ± 5.21

Statistical analysis

AR11 (Amphetamine Sulfate) vs Placebo · Mixed Models Analysis · p = <0.0001

SecondaryPERM-P Scores - Number of Problems Attempted

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).

Time frame:: 0.75, 2, 4, 6, 8, and 10 hours post-dose
Reported as:: Mean · number of problems attempted

PERM-P Scores - Number of Problems Attempted
number of problems attempted	AR11 (Amphetamine Sulfate)	Placebo
0.75 hours post-dose	111.6 ± 53.53	91.2 ± 47.35
2.0 hours post-dose	113.4 ± 51.27	85.7 ± 46.66
4.0 hours post-dose	113.2 ± 56.28	85.1 ± 45.89
6.0 hours post-dose	101.3 ± 54.26	74.9 ± 43.08
8.0 hours post-dose	98.2 ± 56.11	76.4 ± 47.74
10.0 hours post-dose	95.2 ± 55.53	76.3 ± 45.27

Statistical analysis

AR11 (Amphetamine Sulfate) vs Placebo · Mixed Models Analysis · p = <0.0001

SecondaryPERM-P Scores - Number of Problems Correct

Time frame:: 0.75, 2, 4, 6, 8, and 10 hours post-dose
Reported as:: Mean · number of problems correct

PERM-P Scores - Number of Problems Correct
number of problems correct	AR11 (Amphetamine Sulfate)	Placebo
0.75 hours post-dose	104.5 ± 54.49	83.9 ± 46.96
2.0 hours post-dose	107.1 ± 53.15	78.9 ± 44.62
4.0 hours post-dose	107.0 ± 57.46	79.9 ± 45.56
6.0 hours post-dose	95.6 ± 55.43	70.5 ± 43.23
8.0 hours post-dose	92.7 ± 57.28	71.5 ± 47.43
10.0 hours post-dose	89.9 ± 55.29	72.3 ± 45.19

Statistical analysis

AR11 (Amphetamine Sulfate) vs Placebo · Mixed Models Analysis · p = <0.0001

Adverse events

Collected over AE reporting occurred during the 8-week open label treatment phase (i.e. AR11 dose optimization) and the 2-week double blind phase (i.e. crossover period). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AR11	—	0/97 (0%)	19/97 (19.6%)
Placebo	—	0/97 (0%)	6/97 (6.2%)

Most frequent other events

Most frequent other events
Event	AR11	Placebo
Decreased appetiteMetabolism and nutrition disorders	4/97	0/97
InsomniaPsychiatric disorders	3/97	0/97
Upper abdominal painGastrointestinal disorders	3/97	0/97
TachycardiaCardiac disorders	2/97	3/97
Mood swingsPsychiatric disorders	2/97	0/97
Upper respiratory tract infectionInfections and infestations	1/97	2/97
ContusionInjury, poisoning and procedural complications	2/97	0/97
Decreased weightInvestigations	2/97	1/97

Baseline characteristics

Age, Continuous
Age, Continuous(years)	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	Total
Mean	9.6 ± 1.97	9.6 ± 1.78	9.6 ± 1.86

Sex: Female, Male
Sex: Female, Male(Participants)	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	Total
Female	18	20	38
Male	29	30	59

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	13	20	33
White	30	28	58
More than one race	0	0	0
Unknown or Not Reported	3	2	5

Region of Enrollment
Region of Enrollment(participants)	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	Total
United States	47	50	97

Study locations

7 sites

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

References and documents

Publications

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. PubMed 25692608 ↗
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. PubMed 30972657 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01986062
Lead sponsor: Arbor Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Nov 18, 2013
Start date: Dec 2013
Primary completion: May 2014
Completion: May 2014
Results posted: Apr 19, 2016
Last update: Jul 21, 2020

Study contacts

Laurence Downey, MD

study director · Arbor Pharmaceuticals, LLC.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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

Study summary

Conditions studied

Browse trials for

Keywords

In context

Attention Deficit Disorder with Hyperactivity

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria