Trial · NCT01986062

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

NCT01986062, Phase 4, Completed, Arbor Pharmaceuticals, Inc.; results first posted 2016-04-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting. Trials, record NCT01986062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986062

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
NCT number: NCT01986062
Status: Completed
Phases: Phase 4
Enrollment: 97 participants, actual
Lead sponsor: Arbor Pharmaceuticals, Inc.
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Interventions: AR11, Placebo
First posted: 2013-11-18
Last updated: 2020-07-21
Results first posted: 2016-04-19

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	SKAMP-Combined Scores	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.
Secondary	SKAMP-Combined Scores	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.
Secondary	SKAMP Subscale - Attention Scores	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.
Secondary	SKAMP Subscale - Deportment Scores	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.
Secondary	PERM-P Scores - Number of Problems Attempted	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).
Secondary	PERM-P Scores - Number of Problems Correct	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).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	SKAMP-Combined Scores	2 hours post-dose	ITT Population	units on a scale	MEAN
SECONDARY	SKAMP-Combined Scores	0.75, 4, 6, 8, 10 hours post-dose		units on a scale	MEAN
SECONDARY	SKAMP Subscale - Attention Scores	0.75, 2, 4, 6, 8, and 10 hours post-dose		units on a scale	MEAN
SECONDARY	SKAMP Subscale - Deportment Scores	0.75, 2, 4, 6, 8, and 10 hours post-dose		units on a scale	MEAN
SECONDARY	PERM-P Scores - Number of Problems Attempted	0.75, 2, 4, 6, 8, and 10 hours post-dose	ITT	number of problems attempted	MEAN
SECONDARY	PERM-P Scores - Number of Problems Correct	0.75, 2, 4, 6, 8, and 10 hours post-dose	ITT	number of problems correct	MEAN

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
SKAMP-Combined Scores	AR11 (Amphetamine Sulfate)		10.0	Standard Deviation 8.24	units on a scale
SKAMP-Combined Scores	Placebo		17.8	Standard Deviation 1.94	units on a scale
SKAMP-Combined Scores	AR11 (Amphetamine Sulfate)	0.75 hours post-dose	11.8	Standard Deviation 10.56	units on a scale
SKAMP-Combined Scores	Placebo	0.75 hours post-dose	17.3	Standard Deviation 11.38	units on a scale
SKAMP-Combined Scores	AR11 (Amphetamine Sulfate)	4 hours post-dose	11.6	Standard Deviation 10.04	units on a scale
SKAMP-Combined Scores	Placebo	4 hours post-dose	19.8	Standard Deviation 11.92	units on a scale
SKAMP-Combined Scores	AR11 (Amphetamine Sulfate)	6 hours post-dose	14.5	Standard Deviation 10.38	units on a scale
SKAMP-Combined Scores	Placebo	6 hours post-dose	20.2	Standard Deviation 11.28	units on a scale
SKAMP-Combined Scores	AR11 (Amphetamine Sulfate)	8 hours post-dose	16.0	Standard Deviation 11.76	units on a scale
SKAMP-Combined Scores	Placebo	8 hours post-dose	22.0	Standard Deviation 12.33	units on a scale

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	47
Overall Study	STARTED	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	50
Overall Study	COMPLETED	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	46
Overall Study	COMPLETED	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	49
Overall Study	NOT COMPLETED	AR11 (1 Week) Then Placebo (1 Week) - Double Blind	1
Overall Study	NOT COMPLETED	Placebo (1 Week) Then AR11 (1 Week) - Double Blind	1

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Insomnia	Psychiatric disorders	AR11	3	97	3
other	Insomnia	Psychiatric disorders	Placebo	0	97	0
other	Mood swings	Psychiatric disorders	AR11	2	97	2
other	Mood swings	Psychiatric disorders	Placebo	0	97	0
other	Upper abdominal pain	Gastrointestinal disorders	AR11	3	97	3
other	Upper abdominal pain	Gastrointestinal disorders	Placebo	0	97	0
other	Decreased appetite	Metabolism and nutrition disorders	AR11	4	97	4
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	0	97	0
other	Upper respiratory tract infection	Infections and infestations	AR11	1	97	1
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	97	2

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AR11
Total, all-cause mortality	Placebo
Total, other adverse events	AR11	19	97
Total, other adverse events	Placebo	6	97
Total, serious adverse events	AR11	0	97
Total, serious adverse events	Placebo	0	97

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25692608	BACKGROUND	PubMed
30972657	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
AR11 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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