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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder (ADHD)
Interventions Drug: AR11
Drug: Placebo
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AR11 (1 Week) Then Placebo (1 Week) - Double Blind Placebo (1 Week) Then AR11 (1 Week) - Double Blind
Hide Arm/Group Description AR11, administered orally, BID, for one week (crossover to placebo administration week 2) Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
Period Title: Overall Study
Started 47 50
Completed 46 49
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Arm/Group Title AR11 (1 Week) Then Placebo (1 Week) - Double Blind Placebo (1 Week) Then AR11 (1 Week) - Double Blind Total
Hide Arm/Group Description AR11, administered orally, BID for one week (crossover to placebo administration week 2) Placebo, administered orally, BID for one week (crossover to AR11 administration week 2) Total of all reporting groups
Overall Number of Baseline Participants 47 50 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 50 participants 97 participants
9.6  (1.97) 9.6  (1.78) 9.6  (1.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 50 participants 97 participants
Female
18
  38.3%
20
  40.0%
38
  39.2%
Male
29
  61.7%
30
  60.0%
59
  60.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 50 participants 97 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.1%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  27.7%
20
  40.0%
33
  34.0%
White
30
  63.8%
28
  56.0%
58
  59.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   6.4%
2
   4.0%
5
   5.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 50 participants 97 participants
47 50 97
1.Primary Outcome
Title SKAMP-Combined Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title AR11 (Amphetamine Sulfate) Placebo
Hide Arm/Group Description:
AR11, administered orally, BID, 10-40 mg/day
Placebo, administered orally, BID
Overall Number of Participants Analyzed 95 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.0  (8.24) 17.8  (1.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AR11 (Amphetamine Sulfate), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title SKAMP-Combined Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AR11 (Amphetamine Sulfate) Placebo
Hide Arm/Group Description:
AR11, administered orally, BID, 10-40 mg/day
Placebo, administered orally, BID
Overall Number of Participants Analyzed 95 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AR11 (Amphetamine Sulfate), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title SKAMP Subscale - Attention Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AR11 (Amphetamine Sulfate) Placebo
Hide Arm/Group Description:
AR11, administered orally, BID, 10-40 mg/day
Placebo, administered orally, BID
Overall Number of Participants Analyzed 95 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AR11 (Amphetamine Sulfate), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title SKAMP Subscale - Deportment Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AR11 (Amphetamine Sulfate) Placebo
Hide Arm/Group Description:
AR11, administered orally, BID, 10-40 mg/day
Placebo, administered orally, BID
Overall Number of Participants Analyzed 95 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AR11 (Amphetamine Sulfate), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title PERM-P Scores - Number of Problems Attempted
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title AR11 (Amphetamine Sulfate) Placebo
Hide Arm/Group Description:
AR11, administered orally, BID, 10-40 mg/day
Placebo, administered orally, BID
Overall Number of Participants Analyzed 95 97
Mean (Standard Deviation)
Unit of Measure: number of problems attempted
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AR11 (Amphetamine Sulfate), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title PERM-P Scores - Number of Problems Correct
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title AR11 (Amphetamine Sulfate) Placebo
Hide Arm/Group Description:
AR11, administered orally, BID, 10-40 mg/day
Placebo, administered orally, BID
Overall Number of Participants Analyzed 95 97
Mean (Standard Deviation)
Unit of Measure: number of problems correct
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AR11 (Amphetamine Sulfate), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AR11 Placebo
Hide Arm/Group Description AR11, administered orally, BID for one week Placebo, administered orally, BID for one week
All-Cause Mortality
AR11 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
AR11 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/97 (0.00%)      0/97 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
AR11 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/97 (19.59%)      6/97 (6.19%)    
Cardiac disorders     
Tachycardia  1  2/97 (2.06%)  2 3/97 (3.09%)  3
Gastrointestinal disorders     
Upper abdominal pain  1  3/97 (3.09%)  3 0/97 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection  1  1/97 (1.03%)  1 2/97 (2.06%)  2
Injury, poisoning and procedural complications     
Contusion  1  2/97 (2.06%)  2 0/97 (0.00%)  0
Investigations     
Decreased weight  1  2/97 (2.06%)  2 1/97 (1.03%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  4/97 (4.12%)  4 0/97 (0.00%)  0
Psychiatric disorders     
Insomnia  1  3/97 (3.09%)  3 0/97 (0.00%)  0
Mood swings  1  2/97 (2.06%)  2 0/97 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steve Caras
Organization: Arbor Pharmaceuticals
Phone: (470) 235-2327
EMail: scaras@arborpharma.com
Layout table for additonal information
Responsible Party: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01986062    
Other Study ID Numbers: AR11.001
First Submitted: November 11, 2013
First Posted: November 18, 2013
Results First Submitted: June 5, 2015
Results First Posted: April 19, 2016
Last Update Posted: July 21, 2020